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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-02260 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| NRG-GU007 | Other Identifier | NRG Oncology | |
| NRG-GU007 | Other Identifier | CTEP | |
| U10CA180868 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This is a phase I-II trial to find the safety and activity of adding a new drug (neraparib) to the usual treatment (radiation combined with male hormone deprivation therapy) in lowering the chance of prostate cancer growing or returning. Niraparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Adding niraparib to the usual care may lower the chance of prostate cancer growing or returning.
PRIMARY OBJECTIVES:
I. To establish the preferred dose of niraparib in combination with radiation and antiandrogen therapy (ADT). (Phase I) II. To compare the disease-free state, defined as prostate specific antigen (PSA) remaining < 0.1 ng/ml at the end of ADT therapy in men with high risk prostate cancer treated with standard therapy with or without the addition of niraparib. (Phase IIR)
SECONDARY OBJECTIVES:
I. To further establish the safety and toxicity profile of standard treatment with radiation and androgen deprivation therapy specifically, two years from initiation of ADT, plus niraparib at the phase II dose.
II. To compare the overall survival, prostate cancer-specific survival, local/regional or distant progression, and distant metastatic disease rates of standard therapy with or without the addition of niraparib.
EXPLORATORY OBJECTIVE:
I. To identify genomic biomarkers of response to combination therapy with radiation, ADT and PARP inhibition.
OUTLINE: This is a phase I, dose-escalation study of niraparib, followed by a randomized phase II study.
PHASE I: Patients receive niraparib orally (PO) once daily (QD) and receive standard of care gonadotrophin releasing hormone (GnRH) agonist androgen suppression therapy. Treatment with niraparib continues for 12 months, and GnRH agonist therapy for 24 months in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after starting niraparib and GnRH agonist, patients undergo standard of care intensity-modulated radiation therapy (IMRT) 5 days per week for about 6-9 weeks, depending on type of radiation therapy given, in the absence of disease progression or unacceptable toxicity. Patients also undergo magnetic resonance imaging (MRI) on study.
PHASE II: Patients are randomized to 1 of 2 arms:
ARM I: Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months in the absence of disease progression or unacceptable toxicity. Beginning 8-28 weeks after starting GnRH agonist, patients undergo IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy given in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI on study.
ARM II: Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months, and niraparib PO QD for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy given in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI on study.
After completion of study treatment, patients are followed up every 6 months for 3 years, then annually for 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I, Dose Level 1 (niraparib, GnRH, IMRT) | Experimental | Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD* for the first 12 months. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment is given in the absence of disease progression or unacceptable toxicity. *Niraparib dose level 1: 100 mg. |
|
| Phase I, Dose Level 2 (niraparib, GnRH, IMRT) | Experimental | Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD* for the first 12 months. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment is given in the absence of disease progression or unacceptable toxicity. *Niraparib dose level 2: 100 mg during IMRT 200 mg otherwise. |
|
| Phase I, Dose Level 3 (niraparib, GnRH, IMRT) | Experimental | Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD* for the first 12 months. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment given in the absence of disease progression or unacceptable toxicity. *Niraparib dose level 3: 200 mg. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gonadotrophin Releasing Hormone | Biological | Receive standard of care GnRH agonist androgen suppression therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Disease-free Until Completion of Treatment (2 Years From Start of ADT) | Participants will be considered disease-free if their PSA values remain below 0.1 ng/ml until the completion of treatment. The proportion of patients disease-free at 24 months were to be compared in the two treatment arms using a non-continuity-corrected chi-square test. PSA levels will be assessed prior to the start of RT, at the end of RT, and every three months for 24 months. all PSA values obtained up to and including the two-year landmark must be < 0.1 ng/ml. Patients who die prior to two years from prostate cancer will be counted as failures. Patients who die from causes other than prostate cancer will be considered non-evaluable for the primary endpoint. Patients still under follow-up but who have a missing PSA value at two years or more than two missing values prior to two years will also be counted as failures. | Baseline to completion of treatment (two years from start of ADT) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants Alive (Overall Survival) | Survival rates were to be estimated using the Kaplan-Meier method and the treatment arms were to be compared using a log-rank test. | From baseline to death or last follow-up, analyzed after phase II participants have been followed for two years, which was expected to occur 3.5 years from start of phase II component. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Niraparib/ Preferred Niraparib Dose for Phase II Component | MTD was determined using the classic 3+3 design to determine the safety of each dose level (DL) from the number of participants with dose limiting toxicities (DLTs), starting with DL1. The highest DL deemed safe was to be considered the MTD. The timing of the 3-patient cohorts took into account the previously established safety of concurrent ADT and 200 mg niraparib and the need to more clearly establish the safety of niraparib concurrent with RT. A DLT is defined as any treatment-related gastrointestinal or genitourinary grade 3 or higher AE lasting > 1 week, despite maximal medical interventions, and any treatment-related grade 4 AEs lasting > 1 week. Relationship to treatment was determined by the responsible clinician. Study chairs reviewed possible DLTs for final determination. Niraparib dose level (mg PO QD) definitions [First 8 weeks with ADT, 6-8 weeks with ADT and RT, remaining time of the 12 months]:
|
Inclusion Criteria:
Histologically confirmed (within 180 days prior to registration) adenocarcinoma of the prostate at high risk for recurrence as determined by the following criteria, according to American Joint Committee on Cancer (AJCC) 8th edition:
Phase I enrollment
Phase II enrollment
No distant metastases as evaluated by:
History/physical examination within 90 days prior to registration
Age >= 18
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 180 days prior to registration
Pretreatment serum PSA, obtained prior to any androgen suppression therapy and within 180 days of registration
Phase I patients: Prior androgen suppression for prostate cancer is not allowed prior to registration
Phase II patients: Prior androgen suppression for prostate cancer is allowed =< 45 days prior to registration
Hemoglobin >= 9.0 g/dL (within 90 days prior to registration)
Platelets >= 100,000 cells/mm^3 (within 90 days prior to registration)
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (within 90 days prior to registration)
Serum creatinine =<1.5 x upper limit of normal (ULN) OR a calculated creatinine clearance >= 30 mL/min estimated using Cockcroft-Gault equation (within 90 days prior to registration)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x ULN (within 90 days prior to registration)
Serum albumin >= 3 g/dL (within 90 days prior to registration)
Serum potassium >= 3.5 mmol/L (within 90 days prior to registration)
Serum total bilirubin =< 1.5 x ULN or direct bilirubin =< 1 x ULN (Note: in subjects with Gilberts syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin, and if direct bilirubin is =< 1.5 x ULN, subject may be eligible) (within 90 days prior to registration)
Men of child-producing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months afterwards
The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
Exclusion Criteria:
PSA > 150 ng/mL
Definitive clinical or radiologic evidence of metastatic disease
Pathologically positive lymph nodes or nodes > 1.5 cm short axis on CT or MR imaging
Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason
Any active malignancy within 2 years of study registration that may alter the course of prostate cancer treatment
Prior systemic therapy for prostate cancer; note that prior therapy for a different cancer is allowable
Prior radiotherapy, including brachytherapy, to the region of the prostate that would result in overlap of radiation therapy fields
Current treatment with first generation anti-androgens (bicalutamide, nilutamide, flutamide). For patients enrolled to phase II, if prior anti-androgens were administered, a washout period of >= 30 days is required prior to enrollment
Severe, active co-morbidity, defined as follows:
Prior allergic reaction to the drugs involved in this protocol (including known allergies, hypersensitivity or intolerance to the excipients of niraparib)
Human immunodeficiency virus (HIV) positive with CD4 count < 200 cells/microliter
Any history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
Prior or current treatment with PARP inhibitor
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| Name | Affiliation | Role |
|---|---|---|
| M. D Michaelson | NRG Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| University of Arizona Cancer Center-Orange Grove Campus |
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase I, Dose Level 1 (DL1) (Niraparib, GnRH, IMRT) | Patients undergo standard of care gonadotrophin releasing hormone (GnRH) agonist androgen suppression therapy for 24 months, and niraparib PO QD* for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after starting niraparib, patients undergo standard of care intensity-modulated radiation therapy (IMRT) 5 days per week for about 6-9 weeks depending on type of radiation therapy given in the absence of disease progression or unacceptable toxicity. *niraparib dose level 1: 100 mg. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 24, 2022 |
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| Phase II, Arm I (GnRH, IMRT) | Active Comparator | Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months. Beginning 8-28 weeks after starting GnRH agonist, patients undergo IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment is given in the absence of disease progression or unacceptable toxicity. |
|
| Phase II, Arm II (niraparib, GnRH, IMRT) | Experimental | Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD (phase I determined dose level) for the first 12 months. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment is given in the absence of disease progression or unacceptable toxicity. |
|
|
| Intensity-Modulated Radiation Therapy | Radiation | Undergo standard of care IMRT |
|
|
| Niraparib | Drug | tablet |
|
|
| Percentage of Participants With Prostate Cancer Deaths (Prostate Cancer-specific Survival) | Prostate cancer death rates were to be estimated using the cumulative incidence method, treating deaths due to other causes as competing risks. The treatment arms were to be compared using the Fine-Gray test | From baseline to death or last follow-up, analyzed after all phase II participants have been followed for two years, which was expected to occur 3.5 years from start of phase II component. |
| Percentage of Participants With Pathologic Complete Response (pCR) at Two Years | Complete response was to be determined by a12-core biopsy. Treatment arms were to be compared using a chi-square test. | At two years |
| Percentage of Participants With Local/Regional or Distant Progression | Progression rates were to be estimated using the cumulative incidence method, treating deaths as competing risks. The treatment arms were to be compared using the Fine-Gray test | From baseline to local/regional or distant progression, death, or last follow-up, whichever occurs first, analyzed after all phase II participants have been followed for two years, which was expected to occur 3.5 years from start of phase II component. |
| Percentage of Participants With Distant Metastases | Distant metastases rates were to be estimated using the cumulative incidence method, treating death as a competing risk. The treatment arms were to be compared using the Fine-Gray test | From baseline to distant metastasis, death, or last follow-up, analyzed after all phase II participants have been followed for two years, which was expected to occur 3.5 years from start of phase II component. |
| Percentage of Participants Alive Without Biochemical Progression (Biochemical Progression-free Survival) | Biochemical progression is defined as PSA ≥ 2 ng/ml over the nadir PSA, the presence of local, regional, or distant recurrence, or death from prostate cancer. Biochemical progression-free survival rates were to be estimated using the Kaplan-Meier method and the treatment arms were to be compared using a log-rank test. | From baseline to biochemical progression or last follow-up, analyzed after all phase II participants have been followed for two years, which was expected to occur 3.5 years from start of phase II component. |
| Number of Participants by Highest Grade Adverse Event Reported | Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Adverse events were to be categorized as early (within 90 days of completion of radiotherapy) or late (more than 90 days after the completion of radiotherapy).The number of participants per grade was to be compared between the arms for early, late, and all adverse events using chi-square or Fisher exact tests | From baseline to last follow-up, analyzed after all phase II participants have been followed for two years, which was expected to occur 3.5 years from start of phase II component. |
| From start of combined ADT and niraparib to six months |
| Number of Participants Who Experienced Dose-limiting Toxicities (DLT) | A DLT is defined as any treatment-related gastrointestinal or genitourinary grade 3 or higher AE lasting > 1 week, despite maximal medical interventions, and any treatment-related grade 4 AEs lasting > 1 week. Relationship to treatment was determined by the responsible clinician. Study chairs reviewed possible DLTs for final determination. | From start of combined ADT and niraparib to six months |
| Percentage of Participants With Gene Alterations Detected by Targeted Exome Sequencing | The percentage of patients with baseline or post-therapy alterations in targeted genes would be reported and the association between the occurrence of alterations and clinical outcomes would be assessed. | From baseline to death or last follow-up, analyzed after all participants have been followed for two years and gene mutation data produced |
| Percentage of Participants With Gene Expression Determined by High-density Affymetrix Oligonucleotide Array to Profile the Transcriptome of Tumor Samples | The percentage of participants with baseline or post-therapy gene expression and the association between the occurrence of alterations and clinical outcomes would be assessed. | From baseline to death or last follow-up, analyzed after all participants have been followed for two years and gene expression data generated. |
| Percentage of Participants With Single Nucleotide Polymorphisms From Whole Blood Samples | The percentage of patients with baseline or post-therapy polymorphism would be reported and the association between the occurrence of alterations and clinical outcomes would be assessed. | From baseline to death or last follow-up, analyzed after all participants have been followed for two years and polymorphism data generated. |
| Tucson |
| Arizona |
| 85704 |
| United States |
| University of Arizona Cancer Center-North Campus | Tucson | Arizona | 85719 | United States |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Fremont - Rideout Cancer Center | Marysville | California | 95901 | United States |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | United States |
| City of Hope Upland | Upland | California | 91786 | United States |
| Helen F Graham Cancer Center | Newark | Delaware | 19713 | United States |
| Medical Oncology Hematology Consultants PA | Newark | Delaware | 19713 | United States |
| George Washington University Medical Center | Washington D.C. | District of Columbia | 20037 | United States |
| Grady Health System | Atlanta | Georgia | 30303 | United States |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| Emory Saint Joseph's Hospital | Atlanta | Georgia | 30342 | United States |
| CTCA at Southeastern Regional Medical Center | Newnan | Georgia | 30265 | United States |
| Alton Memorial Hospital | Alton | Illinois | 62002 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Rush MD Anderson Cancer Center | Chicago | Illinois | 60612 | United States |
| Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | United States |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | United States |
| University of Kansas Cancer Center-Overland Park | Overland Park | Kansas | 66210 | United States |
| University of Kansas Hospital-Westwood Cancer Center | Westwood | Kansas | 66205 | United States |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | 21201 | United States |
| Central Maryland Radiation Oncology in Howard County | Columbia | Maryland | 21044 | United States |
| UM Baltimore Washington Medical Center/Tate Cancer Center | Glen Burnie | Maryland | 21061 | United States |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
| McLaren Cancer Institute-Bay City | Bay City | Michigan | 48706 | United States |
| Henry Ford Cancer Institute-Downriver | Brownstown | Michigan | 48183 | United States |
| McLaren Cancer Institute-Clarkston | Clarkston | Michigan | 48346 | United States |
| Henry Ford Macomb Hospital-Clinton Township | Clinton Township | Michigan | 48038 | United States |
| Henry Ford Medical Center-Fairlane | Dearborn | Michigan | 48126 | United States |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Weisberg Cancer Treatment Center | Farmington Hills | Michigan | 48334 | United States |
| McLaren Cancer Institute-Flint | Flint | Michigan | 48532 | United States |
| Singh and Arora Hematology Oncology PC | Flint | Michigan | 48532 | United States |
| Karmanos Cancer Institute at McLaren Greater Lansing | Lansing | Michigan | 48910 | United States |
| Mid-Michigan Physicians-Lansing | Lansing | Michigan | 48912 | United States |
| McLaren Cancer Institute-Lapeer Region | Lapeer | Michigan | 48446 | United States |
| McLaren Cancer Institute-Macomb | Mount Clemens | Michigan | 48043 | United States |
| Henry Ford Medical Center-Columbus | Novi | Michigan | 48377 | United States |
| McLaren Cancer Institute-Northern Michigan | Petoskey | Michigan | 49770 | United States |
| McLaren-Port Huron | Port Huron | Michigan | 48060 | United States |
| Henry Ford Macomb Health Center - Shelby Township | Shelby | Michigan | 48315 | United States |
| Henry Ford West Bloomfield Hospital | West Bloomfield | Michigan | 48322 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Siteman Cancer Center at Saint Peters Hospital | City of Saint Peters | Missouri | 63376 | United States |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | 63141 | United States |
| University of Kansas Cancer Center - North | Kansas City | Missouri | 64154 | United States |
| University of Kansas Cancer Center - Lee's Summit | Lee's Summit | Missouri | 64064 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | United States |
| Benefis Sletten Cancer Institute | Great Falls | Montana | 59405 | United States |
| AtlantiCare Health Park-Cape May Court House | Cape May Court House | New Jersey | 08210 | United States |
| AtlantiCare Surgery Center | Egg Harbor | New Jersey | 08234 | United States |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07101 | United States |
| Holy Name Hospital | Teaneck | New Jersey | 07666 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| The New York Hospital Medical Center of Queens | Flushing | New York | 11355 | United States |
| Highland Hospital | Rochester | New York | 14620 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | United States |
| Summa Health System - Akron Campus | Akron | Ohio | 44304 | United States |
| Summa Health System - Barberton Campus | Barberton | Ohio | 44203 | United States |
| University of Cincinnati Cancer Center-UC Medical Center | Cincinnati | Ohio | 45219 | United States |
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| Summa Health Medina Medical Center | Medina | Ohio | 44256 | United States |
| University of Cincinnati Cancer Center-West Chester | West Chester | Ohio | 45069 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Christiana Care Health System-Concord Health Center | Chadds Ford | Pennsylvania | 19317 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| Geisinger Medical Oncology-Lewisburg | Lewisburg | Pennsylvania | 17837 | United States |
| Lewistown Hospital | Lewistown | Pennsylvania | 17044 | United States |
| Eastern Regional Medical Center | Philadelphia | Pennsylvania | 19124 | United States |
| University of Pittsburgh Cancer Institute (UPCI) | Pittsburgh | Pennsylvania | 15232 | United States |
| UPMC-Shadyside Hospital | Pittsburgh | Pennsylvania | 15232 | United States |
| Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania | 18711 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Prisma Health Cancer Institute - Faris | Greenville | South Carolina | 29605 | United States |
| Saint Francis Cancer Center | Greenville | South Carolina | 29607 | United States |
| Prisma Health Cancer Institute - Eastside | Greenville | South Carolina | 29615 | United States |
| Self Regional Healthcare | Greenwood | South Carolina | 29646 | United States |
| Prisma Health Cancer Institute - Greer | Greer | South Carolina | 29650 | United States |
| Prisma Health Cancer Institute - Seneca | Seneca | South Carolina | 29672 | United States |
| West Virginia University Healthcare | Morgantown | West Virginia | 26506 | United States |
| Froedtert Menomonee Falls Hospital | Menomonee Falls | Wisconsin | 53051 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Zablocki Veterans Administration Medical Center | Milwaukee | Wisconsin | 53295 | United States |
| Drexel Town Square Health Center | Oak Creek | Wisconsin | 53154 | United States |
| ProHealth Oconomowoc Memorial Hospital | Oconomowoc | Wisconsin | 53066 | United States |
| UW Cancer Center at ProHealth Care | Waukesha | Wisconsin | 53188 | United States |
| Froedtert West Bend Hospital/Kraemer Cancer Center | West Bend | Wisconsin | 53095 | United States |
| Arthur J E Child Comprehensive Cancer Centre | Calgary | Alberta | T2N 5G2 | Canada |
| FG001 | Phase I, Dose Level 2 (DL2) (Niraparib, GnRH, IMRT) | Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months, and niraparib PO QD* for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy given in the absence of disease progression or unacceptable toxicity. *niraparib dose level 2: 100 mg during IMRT 200 mg all other time. |
| FG002 | Phase I, Dose Level 3 (DL3) (Niraparib, GnRH, IMRT) | Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months, and niraparib PO QD* for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy given in the absence of disease progression or unacceptable toxicity. *niraparib dose level 3: 200 mg. |
| FG003 | Phase II, Arm I (GnRH, IMRT) | Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months in the absence of disease progression or unacceptable toxicity. Beginning 8-28 weeks after starting GnRH agonist, patients undergo IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy given in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI on study. |
| FG004 | Phase II, Arm II (Niraparib, GnRH, IMRT) | Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months, and niraparib PO QD (phase I determined dose level) for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy given in the absence of disease progression or unacceptable toxicity. |
| Eligible and Evaluable |
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| COMPLETED |
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| NOT COMPLETED |
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|
Eligible and evaluable phase I participants. (Phase II component will not open.)
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase I, Dose Level 1 (Niraparib, GnRH, IMRT) | Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD* for the first 12 months. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment is given in the absence of disease progression or unacceptable toxicity. *niraparib dose level 1: 100 mg. |
| BG001 | Phase I, Dose Level 2 (Niraparib, GnRH, IMRT) | Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD* for the first 12 months. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment is given in the absence of disease progression or unacceptable toxicity. *niraparib dose level 2: 100 mg during IMRT 200 mg otherwise. |
| BG002 | Phase I, Dose Level 3 (Niraparib, GnRH, IMRT) | Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD* for the first 12 months. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment given in the absence of disease progression or unacceptable toxicity. *niraparib dose level 3: 200 mg. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| T-Stage | Tumor stage per the American Joint Committee on Cancer (AJCC) X8h ed. refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues.
| Count of Participants | Participants |
| |||||||||||||||
| N-Stage | Regional lymph nodes staging per American Joint Committee on Cancer (AJCC) 8th ed. refers to the number and/or extent of spread of lymph nodes that contain cancer:
| Count of Participants | Participants |
| |||||||||||||||
| Gleason score | Gleason score describes prostate cancer based on how abnormal the cancer cells in a biopsy sample look under a microscope. Cells are scored 1-5 with 1 indicating "low-grade" looking similar to normal cells and 5 indicating "high-grade" barely resembling normal cells due to mutation. A pathologist assigns a Gleason grade to the first and second most predominant patterns in the biopsy. The two grades are added together to calculate the Gleason score (between 2 and 10). Cancers with lower scores tend to be less aggressive, while cancers with higher scores end to be more aggressive. | Count of Participants | Participants |
| |||||||||||||||
| Baseline Prostate-specific antigen (PSA) | Prostate-specific antigen (PSA) is a protein made by the prostate gland and found in the blood. PSA blood levels may be higher than normal in men who have prostate cancer, benign prostatic hyperplasia (BPH), or infection or inflammation of the prostate gland, and are often used to monitor patients who have been treated for prostate cancer to see if their cancer has recurred. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Disease-free Until Completion of Treatment (2 Years From Start of ADT) | Participants will be considered disease-free if their PSA values remain below 0.1 ng/ml until the completion of treatment. The proportion of patients disease-free at 24 months were to be compared in the two treatment arms using a non-continuity-corrected chi-square test. PSA levels will be assessed prior to the start of RT, at the end of RT, and every three months for 24 months. all PSA values obtained up to and including the two-year landmark must be < 0.1 ng/ml. Patients who die prior to two years from prostate cancer will be counted as failures. Patients who die from causes other than prostate cancer will be considered non-evaluable for the primary endpoint. Patients still under follow-up but who have a missing PSA value at two years or more than two missing values prior to two years will also be counted as failures. | Eligible and evaluable phase II participants followed for two years after start of ADT. The study did/will not advance to the phase II component. | Posted | Baseline to completion of treatment (two years from start of ADT) |
|
| ||||||||||||||||||||||
| Secondary | Percent of Participants Alive (Overall Survival) | Survival rates were to be estimated using the Kaplan-Meier method and the treatment arms were to be compared using a log-rank test. | Eligible phase II participants. The study did/will not advance to the phase II component. | Posted | From baseline to death or last follow-up, analyzed after phase II participants have been followed for two years, which was expected to occur 3.5 years from start of phase II component. |
| |||||||||||||||||||||||
| Secondary | Percentage of Participants With Prostate Cancer Deaths (Prostate Cancer-specific Survival) | Prostate cancer death rates were to be estimated using the cumulative incidence method, treating deaths due to other causes as competing risks. The treatment arms were to be compared using the Fine-Gray test | Eligible phase II participants. The study did/will not advance to the phase II component. | Posted | From baseline to death or last follow-up, analyzed after all phase II participants have been followed for two years, which was expected to occur 3.5 years from start of phase II component. |
| |||||||||||||||||||||||
| Secondary | Percentage of Participants With Pathologic Complete Response (pCR) at Two Years | Complete response was to be determined by a12-core biopsy. Treatment arms were to be compared using a chi-square test. | Eligible phase II participants with 12-core biopsy at 24 months. The study did/will not advance to the phase II component. | Posted | At two years |
| |||||||||||||||||||||||
| Secondary | Percentage of Participants With Local/Regional or Distant Progression | Progression rates were to be estimated using the cumulative incidence method, treating deaths as competing risks. The treatment arms were to be compared using the Fine-Gray test | Eligible phase II participants. The study did/will not advance to the phase II component. | Posted | From baseline to local/regional or distant progression, death, or last follow-up, whichever occurs first, analyzed after all phase II participants have been followed for two years, which was expected to occur 3.5 years from start of phase II component. |
| |||||||||||||||||||||||
| Secondary | Percentage of Participants With Distant Metastases | Distant metastases rates were to be estimated using the cumulative incidence method, treating death as a competing risk. The treatment arms were to be compared using the Fine-Gray test | Eligible phase II participants. The study did not and will not advance to the phase II component. | Posted | From baseline to distant metastasis, death, or last follow-up, analyzed after all phase II participants have been followed for two years, which was expected to occur 3.5 years from start of phase II component. |
| |||||||||||||||||||||||
| Secondary | Percentage of Participants Alive Without Biochemical Progression (Biochemical Progression-free Survival) | Biochemical progression is defined as PSA ≥ 2 ng/ml over the nadir PSA, the presence of local, regional, or distant recurrence, or death from prostate cancer. Biochemical progression-free survival rates were to be estimated using the Kaplan-Meier method and the treatment arms were to be compared using a log-rank test. | Eligible phase II participants. The study did/will not advance to the phase II component. | Posted | From baseline to biochemical progression or last follow-up, analyzed after all phase II participants have been followed for two years, which was expected to occur 3.5 years from start of phase II component. |
| |||||||||||||||||||||||
| Secondary | Number of Participants by Highest Grade Adverse Event Reported | Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Adverse events were to be categorized as early (within 90 days of completion of radiotherapy) or late (more than 90 days after the completion of radiotherapy).The number of participants per grade was to be compared between the arms for early, late, and all adverse events using chi-square or Fisher exact tests | Eligible phase II participants. The study did not and will not advance to the phase II component. | Posted | From baseline to last follow-up, analyzed after all phase II participants have been followed for two years, which was expected to occur 3.5 years from start of phase II component. |
| |||||||||||||||||||||||
| Other Pre-specified | Maximum Tolerated Dose (MTD) of Niraparib/ Preferred Niraparib Dose for Phase II Component | MTD was determined using the classic 3+3 design to determine the safety of each dose level (DL) from the number of participants with dose limiting toxicities (DLTs), starting with DL1. The highest DL deemed safe was to be considered the MTD. The timing of the 3-patient cohorts took into account the previously established safety of concurrent ADT and 200 mg niraparib and the need to more clearly establish the safety of niraparib concurrent with RT. A DLT is defined as any treatment-related gastrointestinal or genitourinary grade 3 or higher AE lasting > 1 week, despite maximal medical interventions, and any treatment-related grade 4 AEs lasting > 1 week. Relationship to treatment was determined by the responsible clinician. Study chairs reviewed possible DLTs for final determination. Niraparib dose level (mg PO QD) definitions [First 8 weeks with ADT, 6-8 weeks with ADT and RT, remaining time of the 12 months]:
| Eligible and evaluable phase I participants. | Posted | Number | Dose level | From start of combined ADT and niraparib to six months |
| |||||||||||||||||||||
| Other Pre-specified | Number of Participants Who Experienced Dose-limiting Toxicities (DLT) | A DLT is defined as any treatment-related gastrointestinal or genitourinary grade 3 or higher AE lasting > 1 week, despite maximal medical interventions, and any treatment-related grade 4 AEs lasting > 1 week. Relationship to treatment was determined by the responsible clinician. Study chairs reviewed possible DLTs for final determination. | Eligible and evaluable phase I participants. | Posted | Count of Participants | Participants | From start of combined ADT and niraparib to six months |
| |||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Gene Alterations Detected by Targeted Exome Sequencing | The percentage of patients with baseline or post-therapy alterations in targeted genes would be reported and the association between the occurrence of alterations and clinical outcomes would be assessed. | Eligible phase II participants with gene alteration data. The study did not and will not advance to the phase II component. | Posted | From baseline to death or last follow-up, analyzed after all participants have been followed for two years and gene mutation data produced |
| |||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Gene Expression Determined by High-density Affymetrix Oligonucleotide Array to Profile the Transcriptome of Tumor Samples | The percentage of participants with baseline or post-therapy gene expression and the association between the occurrence of alterations and clinical outcomes would be assessed. | Eligible phase II participants with gene expression data. The study did not and will not advance to the phase II component. | Posted | From baseline to death or last follow-up, analyzed after all participants have been followed for two years and gene expression data generated. |
| |||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Single Nucleotide Polymorphisms From Whole Blood Samples | The percentage of patients with baseline or post-therapy polymorphism would be reported and the association between the occurrence of alterations and clinical outcomes would be assessed. | Eligible phase II participants with polymorphism data. The study did not and will not advance to the phase II component. | Posted | From baseline to death or last follow-up, analyzed after all participants have been followed for two years and polymorphism data generated. |
|
From baseline to last follow-up. Maximum follow-up was 4.6 years.
All-cause mortality and adverse events were assessed in eligible and evaluable phase I participants. The study did not and will not advance to the phase II component.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase I, Dose Level 1 (Niraparib, GnRH, IMRT) | Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD* for the first 12 months. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment is given in the absence of disease progression or unacceptable toxicity. *Niraparib dose level 1: 100 mg. | 0 | 6 | 3 | 6 | 6 | 6 |
| EG001 | Phase I, Dose Level 2 (Niraparib, GnRH, IMRT) | Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD* for the first 12 months. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment is given in the absence of disease progression or unacceptable toxicity. *Niraparib dose level 2: 100 mg during IMRT 200 mg otherwise. | 0 | 5 | 3 | 5 | 5 | 5 |
| EG002 | Phase I, Dose Level 3 (Niraparib, GnRH, IMRT) | Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD* for the first 12 months. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment given in the absence of disease progression or unacceptable toxicity. *Niraparib dose level 3: 200 mg. | 0 | 6 | 3 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANEMIA | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| CHEST PAIN - CARDIAC | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| LIMBAL STEM CELL DEFICIENCY | Eye disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| DIARRHEA | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| HEMORRHOIDAL HEMORRHAGE | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| PROCTITIS | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| RECTAL HEMORRHAGE | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| RECTAL PAIN | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| PAIN | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| ABDOMINAL INFECTION | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| COVID | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| LYMPHOCYTE COUNT DECREASED | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| WHITE BLOOD CELL DECREASED | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| HYPERGLYCEMIA | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| HYPOKALEMIA | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| SEIZURE | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| NOCTURIA | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| URINARY URGENCY | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| SINUS CONGESTION | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| YEAST INFECTION (R) GROIN | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| HOT FLASHES | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| THROMBOEMBOLIC EVENT | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANEMIA | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| DECREASED HEMATOCRIT | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| DECREASED MEAN CORPUSCULAR HEMOGLOBIN CONCENTRATION | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| DECREASED TOTAL PROTEIN | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| ELEVATED BLOOD UREA NITROGEN | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| EOSINOPHILIA | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| RED BLOOD CELL DECREASED | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| CHEST PAIN - CARDIAC | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| SINUS TACHYCARDIA | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| EAR PAIN | Ear and labyrinth disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| HYPERTHYROIDISM | Endocrine disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| BLOATING | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| DIARRHEA | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| FLATULENCE | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| GLUTEN AND LACTOSE INTOLERANCE | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| HEMORRHOIDAL HEMORRHAGE | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| HEMORRHOIDS | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| PROCTITIS | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| RECTAL HEMORRHAGE | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| RECTAL MUCOSITIS | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| TENESMUS | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| CHILLS | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| EDEMA LIMBS | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| FATIGUE | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| FLU LIKE SYMPTOMS | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| GENERALIZED EDEMA | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| INJECTION SITE REACTION | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| PAIN | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| SINUS INFECTION | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| SINUSITIS | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| SKIN INFECTION | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| UPPER RESPIRATORY INFECTION | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | CTCAE (5.0) | Non-systematic Assessment |
| |
| SPINAL FRACTURE | Injury, poisoning and procedural complications | CTCAE (5.0) | Non-systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| ALKALINE PHOSPHATASE INCREASED | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| BLOOD BILIRUBIN INCREASED | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| BLOOD LACTATE DEHYDROGENASE INCREASED | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| CREATININE INCREASED | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| LYMPHOCYTE COUNT DECREASED | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| WEIGHT GAIN | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| WEIGHT LOSS | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| WHITE BLOOD CELL DECREASED | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| ANOREXIA | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| HYPERCALCEMIA | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| HYPERGLYCEMIA | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| HYPERKALEMIA | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| HYPERTRIGLYCERIDEMIA | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| HYPOALBUMINEMIA | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| HYPOCALCEMIA | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| HYPOKALEMIA | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| HYPONATREMIA | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| ARTHRITIS | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| GENERALIZED MUSCLE WEAKNESS | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| MUSCLE CRAMP | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| ATAXIA | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| COGNITIVE DISTURBANCE | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| DYSESTHESIA | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| TREMOR | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| HEMATURIA | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| NOCTURIA | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| PROTEINURIA | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| RADIATION CYSTITIS | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| STOP AND START URINATION | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| STRAIN TO BEGIN URINATION | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| URINARY FREQUENCY | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| URINARY HESITANCY | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| URINARY INCONTINENCE | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| URINARY TRACT OBSTRUCTION | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| URINARY URGENCY | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| WEAK STREAM | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| ERECTILE DYSFUNCTION | Reproductive system and breast disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| DYSPNEA | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| SINUS CONGESTION | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| RASH ACNEIFORM | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| VERY SMALL AMOUNT OF BLOOD ON TISSUE WHEN WIPES AT TIMES | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| HOT FLASHES | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| PERIPHERAL ISCHEMIA | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
|
This study closed accrual permanently without proceeding to the phase II component because the standard of care for prostate cancer in this population substantially evolved and incorporation of the new standard would have required a much larger sample size. Therefore, only phase I results can be reported, appearing as "other pre-specified" outcome measures because although listed as a primary objective in the protocol, they are not explicitly listed as primary or secondary statistical endpoints.
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Seiferheld | NRG Oncology | 215-574-3208 | seiferheldw@nrgoncology.org |
| Jun 24, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 24, 2022 | Jun 24, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D050397 | Radiotherapy, Intensity-Modulated |
| C545685 | niraparib |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
| T2 |
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| T3 |
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| T4 |
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| N1 |
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| 10 |
|
| PSA ≥ 20-150 ng/mL |
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| Units | Counts |
|---|---|
| Participants |
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Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months, and niraparib PO QD (phase I determined dose level) for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy given in the absence of disease progression or unacceptable toxicity.
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| OG002 | Phase I, Dose Level 3 (Niraparib, GnRH, IMRT) | Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months, and niraparib PO QD* for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy given in the absence of disease progression or unacceptable toxicity. *niraparib dose level 3: 200 mg. |
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