Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-02192 | Registry Identifier | NCI CTRP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This phase 2 trial studies radium Ra 223 dichloride, hormone therapy and stereotactic body radiation in treating patients with prostate cancer that has spread to other places in the body. Radium Ra 223 dichloride contains a radioactive substance that collects in the bone and gives off radiation that may kill cancer cells. Hormone therapy using leuprolide acetate or goserelin acetate may fight prostate cancer by lowering the amount of testosterone the body makes. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Giving radium Ra 223 dichloride, hormone therapy and stereotactic body radiation may work better at treating prostate cancer.
PRIMARY OBJECTIVES:
I. To assess the time to treatment failure (TTF) in patients who initiated the protocol regimen of androgen deprivation therapy (ADT) with stereotactic body radiation therapy (SBRT) and radium Ra 223 dichloride and received at least one dose with radium Ra 223 dichloride.
SECONDARY OBJECTIVES:
I. To assess the safety of adding radium Ra 223 dichloride to SBRT and ADT in patients with oligometastatic castration sensitive prostate cancer.
II. To assess the prostate-specific antigen (PSA) and overall response rate (ORR) after 6 cycles of radium Ra 223 dichloride (cycle 8 day 1).
III. To assess the progression-free survival (PFS) in patients with oligometastatic castration sensitive prostate cancer who initiated the protocol regimen of ADT with SBRT and radium Ra 223 dichloride and received at least one dose of radium Ra 223 dichloride.
IV. To assess time to bone specific PFS in patients with oligometastatic castration sensitive prostate cancer who initiated the protocol regimen of ADT with SBRT and radium Ra 223 dichloride and received at least one dose of radium Ra 223 dichloride.
V. To assess overall survival, complete response rate, duration of response, and duration of overall complete response and duration of stable disease in patients with oligometastatic castration sensitive prostate cancer who initiated the protocol regimen of ADT with SBRT and radium Ra 223 dichloride.
VI. To assess long-term toxicities during 5-year follow-up in patients with oligometastatic castration sensitive prostate cancer who initiated the protocol regimen of ADT with SBRT and radium Ra 223 dichloride and received at least one dose of radium Ra 223 dichloride.
TERTIARY OBJECTIVES:
I. To perform exploratory analysis of primary or metastatic tumor mutation patterns in this study population at baseline.
II. To identify immune system factors in the blood that change during the course of ADT-radiotherapy for metastatic prostate cancer.
III. To describe the rate of normalization of the total alkaline phosphatase level (defined as a return to a value within the normal range) at the end of protocol therapy in patients oligometastatic castration sensitive prostate cancer with total alkaline phosphatase values above the upper limit of the normal range at baseline.
OUTLINE:
Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, or degarelix for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride intravenously (IV) over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 5 years.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (hormone therapy, SBRT, radium Ra 223 dichloride) | Experimental | Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leuprolide Acetate | Drug | Intramuscular or subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Treatment Failure | Defined as time from the initiation of androgen deprivation therapy (ADT) for metastatic disease until PSA increase to > pre-ADT level or PSA > 10 (whichever is smaller) or radiographic or clinical progression or resumption of ADT by physician's choice. | Assessed up to 5 years |
| Objective Response Rate | Response will be evaluated in this study using the modified Prostate Cancer Working Group 2 criteria. Per Prostate Cancer Working Group 2 criteria for target lesions: Complete Response (CR), Disappearance of all target lesions. Lymph node CR is when the lymph node has decreased to less than 10mm in the short axis; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; For non-target lesions, CR: Disappearance of all non-target lesions and PSA level <0.04 (undetectable). Overall Response (OR) = CR + PR. Proportion of patients achieving CR or PR at course 8, day 1 (post 6 doses of radium Ra 223 dichloride) were reported. | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Progression will be evaluated in this study using the modified Prostate Cancer Working Group 2 criteria. Per Prostate Cancer Working Group 2 criteria for target lesions: Progressive Disease (PD), At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started (including the baseline scan if that is the smallest), and at least a 5mm increase or the appearance of new lesions; For non-target lesions, PD: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. PSA increase by ≥ 25 % over baseline and to at least PSA >2 ng/mL. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Normalization of the Total Alkaline Phosphatase Level | The rate of normalization of the total alkaline phosphatase level (defined as a return to a value within the normal range) at the end of protocol therapy in patients with total alkaline phosphatase values above the upper limit of the normal range at baseline will be assessed. | Baseline up to 5 years |
Inclusion Criteria:
Documented informed consent of participant and/or legally authorized representative
Agreement to provide archival primary or metastatic tumor tissue if available
Eastern Cooperative Oncology Group (ECOG) =< 2
Life expectancy > 12 months
Histologic diagnosis of prostate adenocarcinoma
* Pure small cell carcinoma will be excluded; however, component of neuroendocrine /small cell differentiation will be allowed provided that adenocarcinoma constitutes majority of the tissue specimen
Stage M1
* Metastatic disease can be documented by bone scan or computed tomography (CT) scan or magnetic resonance imaging (MRI) or positron emission tomography (PET)/CT or the combination of these tests
Up to 4 metastatic lesions:
Two lesions can be in close proximity (i.e. within 5 cm of each other) if they meet radiation SBRT normal tissue toxicity requirements
If have untreated primary prostate cancer: must undergo debulking prostatectomy
If had prior definitive radiation therapy to the prostate: no evidence of locally persistent or recurrent prostate cancer on digital rectal exam (DRE) and imaging studies (CT or MRI); retreatment to local residual-recurrent disease will result in potential eligibility to be reviewed by PI on a case-by-case basis
Does not have castration resistant disease
* Castration resistance defined as progression of disease despite serum testosterone level of < 50 ng/dL
PSA >= 0.2 prior to start of androgen deprivation treatment
Initiated 28 (+ 7) days of androgen deprivation therapy (ADT) prior to day 1 of protocol therapy
* Only luteinizing hormone-releasing hormone (LHRH) agonist/antagonist treatment is considered ADT, bicalutamide or other antiandrogens used alone do not count
May have received prior hormonal therapy in the context of definitive treatment of a primary tumor
* Patients may have had one prior systemic non-chemotherapeutic treatment (i.e. immunotherapy, receptor tyrosine kinase inhibitor, antiangiogenic agent, differentiating agent) for recurrent or metastatic disease
Must have refused standard of care chemotherapy for metastatic disease
Recovered from all acute side-effects (except alopecia) related to previous systemic therapy
Absolute neutrophil count (ANC) >= 1,500/mm^3 (to be performed within 14 days prior to day 1 of protocol therapy)
* NOTE: growth factor support is not permitted to normalize baseline ANC parameters, however subsequent growth factor administration is permitted as standard supportive care
Platelets >= 100,000/mm^3 (to be performed within 14 days prior to day 1 of protocol therapy)
* NOTE: transfusion of blood products are not allowed to normalize baseline blood parameters, however subsequent transfusions are allowed per standard supportive care guidelines
Hemoglobin (HgB) >= 9.0 g/dL (to be performed within 14 days prior to day 1 of protocol therapy)
* NOTE: transfusion of blood products are not allowed to normalize baseline blood parameters, however subsequent transfusions are allowed per standard supportive care guidelines
Total serum bilirubin =< 2 x upper limit of normal (ULN) (to be performed within 14 days prior to day 1 of protocol therapy)
Aspartate aminotransferase (AST) =< 2.5 x ULN (to be performed within 14 days prior to day 1 of protocol therapy)
Alanine aminotransferase (ALT) =< 2.5 x ULN (to be performed within 14 days prior to day 1 of protocol therapy)
Creatinine =< 2.5 mg/dL (to be performed within 14 days prior to day 1 of protocol therapy)
Exclusion Criteria:
Prior radium Ra 223 dichloride
Prior or concomitant chemotherapy for metastatic or recurrent disease with the following exceptions:
Prior radiation treatment for metastatic disease
Concomitant radiation treatment to primary prostate site
Orchiectomy
Unstable medical comorbidities (i.e. uncontrolled cardiac comorbidities)
Metastases that in the judgment of investigator-radiologist are not amenable to SBRT
History of brain metastases or who currently have treated or untreated brain metastases
Uncontrolled human immunodeficiency virus (HIV) infection
Any other condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Savita Dandapani, MD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
Not provided
25 patients were enrolled between August 2018 and July 2023, including 6 de novo and 19 oligoprogressive mCSPC patients. 1 patient did not receive any cycles of Ra-223 and thus was excluded from analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) | Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| 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 | Aug 3, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Goserelin Acetate | Drug | Subcutaneous injection |
|
|
| Stereotactic Body Radiation Therapy | Radiation | Undergo SBRT |
|
|
| Radium Ra 223 Dichloride | Radiation | Given IV |
|
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Degarelix | Drug | Subcutaneous injection |
|
|
| From the initiation of ADT for metastatic disease until PSA progression or radiographic progression or death, assessed up to 5 years |
| Overall Survival | From date of initiation of protocol treatment to date of death from any cause, assessed up to 5 years |
| Complete Response (CR) Rate Defined as the Proportion of Patients Achieving CR | Response will be evaluated in this study using the modified Prostate Cancer Working Group 2 criteria. Per Prostate Cancer Working Group 2 criteria for target lesions: Complete Response (CR), Disappearance of all target lesions. Lymph node CR is when the lymph node has decreased to less than 10mm in the short axis; For non-target lesions, CR: Disappearance of all non-target lesions and PSA level <0.04 (undetectable). | Up to 5 years |
| Duration of Response | Response will be evaluated in this study using modified Prostate Cancer Working Group 2 criteria. | From documented response to recurrent or progressive disease is first met, assessed up to 5 years |
| Duration of Overall Complete Response | Response will be evaluated in this study using modified Prostate Cancer Working Group 2 criteria. | From documented CR to recurrent/ progressive disease, assessed up to 5 years |
| Bone Specific Progression-free Survival | Progression will be evaluated in this study using modified Prostate Cancer Working Group 2 criteria. Progression will be evaluated in this study using the modified Prostate Cancer Working Group 2 criteria. Per Prostate Cancer Working Group 2 criteria for target lesions: Progressive Disease (PD), At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started (including the baseline scan if that is the smallest), and at least a 5mm increase or the appearance of new lesions; For non-target lesions, PD: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. PSA increase by ≥ 25 % over baseline and to at least PSA >2 ng/mL. | Time to progression of bone specific disease over baseline, assessed up to 5 years |
| Duration of Stable Disease | Response will be evaluated in this study using modified Prostate Cancer Working Group 2 criteria. | Time from start of treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, assessed up to 5 years |
| Number of Participants With Adverse Events (AE) Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Toxicity will be graded. The highest AE grade per cycle will be reported in the electronic case report form (eCRF) from start of therapy until the end of treatment visit. | Up to 5 years |
| Genomic Mutations Analysis | Up to 5 years |
| Immune Biomarker Analysis | Up to 5 years |
| FG001 | Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) | Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) | Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection |
| BG001 | Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) | Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Time to Treatment Failure | Defined as time from the initiation of androgen deprivation therapy (ADT) for metastatic disease until PSA increase to > pre-ADT level or PSA > 10 (whichever is smaller) or radiographic or clinical progression or resumption of ADT by physician's choice. | Posted | Median | 95% Confidence Interval | months | Assessed up to 5 years |
|
|
| |||||||||||||||||||||||||||||
| Primary | Objective Response Rate | Response will be evaluated in this study using the modified Prostate Cancer Working Group 2 criteria. Per Prostate Cancer Working Group 2 criteria for target lesions: Complete Response (CR), Disappearance of all target lesions. Lymph node CR is when the lymph node has decreased to less than 10mm in the short axis; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; For non-target lesions, CR: Disappearance of all non-target lesions and PSA level <0.04 (undetectable). Overall Response (OR) = CR + PR. Proportion of patients achieving CR or PR at course 8, day 1 (post 6 doses of radium Ra 223 dichloride) were reported. | Posted | Count of Participants | Participants | Up to 5 years |
| ||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Progression will be evaluated in this study using the modified Prostate Cancer Working Group 2 criteria. Per Prostate Cancer Working Group 2 criteria for target lesions: Progressive Disease (PD), At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started (including the baseline scan if that is the smallest), and at least a 5mm increase or the appearance of new lesions; For non-target lesions, PD: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. PSA increase by ≥ 25 % over baseline and to at least PSA >2 ng/mL. | Posted | Median | 95% Confidence Interval | months | From the initiation of ADT for metastatic disease until PSA progression or radiographic progression or death, assessed up to 5 years |
| |||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Posted | Median | 95% Confidence Interval | months | From date of initiation of protocol treatment to date of death from any cause, assessed up to 5 years |
| ||||||||||||||||||||||||||||||||
| Secondary | Complete Response (CR) Rate Defined as the Proportion of Patients Achieving CR | Response will be evaluated in this study using the modified Prostate Cancer Working Group 2 criteria. Per Prostate Cancer Working Group 2 criteria for target lesions: Complete Response (CR), Disappearance of all target lesions. Lymph node CR is when the lymph node has decreased to less than 10mm in the short axis; For non-target lesions, CR: Disappearance of all non-target lesions and PSA level <0.04 (undetectable). | Posted | Count of Participants | Participants | Up to 5 years |
| ||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Response will be evaluated in this study using modified Prostate Cancer Working Group 2 criteria. | No patient achieved a complete or partial response; therefore, the duration of response could not be calculated. | Posted | From documented response to recurrent or progressive disease is first met, assessed up to 5 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Duration of Overall Complete Response | Response will be evaluated in this study using modified Prostate Cancer Working Group 2 criteria. | No patient achieved a complete or partial response; therefore, the duration of response could not be calculated. | Posted | From documented CR to recurrent/ progressive disease, assessed up to 5 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Bone Specific Progression-free Survival | Progression will be evaluated in this study using modified Prostate Cancer Working Group 2 criteria. Progression will be evaluated in this study using the modified Prostate Cancer Working Group 2 criteria. Per Prostate Cancer Working Group 2 criteria for target lesions: Progressive Disease (PD), At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started (including the baseline scan if that is the smallest), and at least a 5mm increase or the appearance of new lesions; For non-target lesions, PD: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. PSA increase by ≥ 25 % over baseline and to at least PSA >2 ng/mL. | Posted | Median | 95% Confidence Interval | months | Time to progression of bone specific disease over baseline, assessed up to 5 years |
| |||||||||||||||||||||||||||||||
| Secondary | Duration of Stable Disease | Response will be evaluated in this study using modified Prostate Cancer Working Group 2 criteria. | Only the 23 patients who had a best response of stable disease were included in this analysis. | Posted | Median | 95% Confidence Interval | months | Time from start of treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, assessed up to 5 years |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AE) Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Toxicity will be graded. The highest AE grade per cycle will be reported in the electronic case report form (eCRF) from start of therapy until the end of treatment visit. | Posted | Count of Participants | Participants | Up to 5 years |
| ||||||||||||||||||||||||||||||||
| Other Pre-specified | Rate of Normalization of the Total Alkaline Phosphatase Level | The rate of normalization of the total alkaline phosphatase level (defined as a return to a value within the normal range) at the end of protocol therapy in patients with total alkaline phosphatase values above the upper limit of the normal range at baseline will be assessed. | Not Posted | Baseline up to 5 years | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Genomic Mutations Analysis | Not Posted | Up to 5 years | Participants | |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Immune Biomarker Analysis | Not Posted | Up to 5 years | Participants |
Adverse events were assessed from the time of initial treatment until the end of treatment up to 5 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
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 | De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) | Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection | 1 | 6 | 0 | 6 | 6 | 6 |
| EG001 | Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) | Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection | 5 | 18 | 0 | 18 | 18 | 18 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Chest pain - cardiac | Cardiac disorders | Non-systematic Assessment |
| ||
| Sinus bradycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Sinus tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Blurred vision | Eye disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Bloating | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Esophagitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Intestinal Spasm | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Proctitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Rectal hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Rectal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Stool Urgency | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Edema limbs | General disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Pain | General disorders | Non-systematic Assessment |
| ||
| Sweats | General disorders | Non-systematic Assessment |
| ||
| Biliary Obstruction | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Cholecystitis | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Mucosal infection | Infections and infestations | Non-systematic Assessment |
| ||
| Papulopustular rash | Infections and infestations | Non-systematic Assessment |
| ||
| Sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Upper respiratory infection | Infections and infestations | Non-systematic Assessment |
| ||
| Bruising | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Hip fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Spinal fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Wrist fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Non-systematic Assessment |
| ||
| Blood bicarbonate decreased | Investigations | Non-systematic Assessment |
| ||
| Blood bilirubin increased | Investigations | Non-systematic Assessment |
| ||
| Cholesterol high | Investigations | Non-systematic Assessment |
| ||
| Creatinine increased | Investigations | Non-systematic Assessment |
| ||
| Lymphocyte count decreased | Investigations | Non-systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Non-systematic Assessment |
| ||
| Platelet count decreased | Investigations | Non-systematic Assessment |
| ||
| Weight gain | Investigations | Non-systematic Assessment |
| ||
| Weight loss | Investigations | Non-systematic Assessment |
| ||
| White blood cell decreased | Investigations | Non-systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypercalcemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypermagnesemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypernatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypertriglyceridemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypocalcemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypomagnesemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Obesity | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Back Stiffness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Bone pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Chest wall pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Flank pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Muscle Stiffness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Musculoskeletal Pains | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Osteoporosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Scc On R Forearm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Memory impairment | Nervous system disorders | Non-systematic Assessment |
| ||
| Paresthesia | Nervous system disorders | Non-systematic Assessment |
| ||
| Peripheral sensory neuropathy | Nervous system disorders | Non-systematic Assessment |
| ||
| Presyncope | Nervous system disorders | Non-systematic Assessment |
| ||
| Stroke | Nervous system disorders | Non-systematic Assessment |
| ||
| Syncope | Nervous system disorders | Non-systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
| ||
| Confusion | Psychiatric disorders | Non-systematic Assessment |
| ||
| Hallucinations | Psychiatric disorders | Non-systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
| ||
| Chronic kidney disease | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Glucosuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Nocturia | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Proteinuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary frequency | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary incontinence | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary tract pain | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary urgency | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urine discoloration | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Erectile dysfunction | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Gynecomastia | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pharyngeal mucositis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Sore throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Wheezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Cold Sore | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Dry skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Fever Blisters Lower Lip | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Nail changes | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Nipple Tenderness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Redness L Shoulder | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Skin Boils | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Hot flashes | Vascular disorders | Non-systematic Assessment |
| ||
| Hypertension | Vascular disorders | Non-systematic Assessment |
| ||
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Frankel, Ph.D. | City of Hope | 6262185265 | pfrankel@coh.org |
| Feb 17, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 13, 2023 | Feb 17, 2026 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D016729 | Leuprolide |
| C493311 | luprolide acetate gel depot |
| D017273 | Goserelin |
| D016634 | Radiosurgery |
| C581106 | radium Ra 223 dichloride |
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| 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 |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Male |
|
| Asian |
|
| Hispanic/Latino |
|
| White |
|
| Unknown |
|
Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection |
|
|
| OG001 |
| Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) |
Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection |
|
|
|
|
|
|
|
|
| OG001 | Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) | Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection |
|
|
|
|
|
|