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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-01170 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This pilot clinical trial studies magnetic resonance (MRI)-guided focal stereotactic radiosurgery (SRS) in treating patients with low- or intermediate-risk localized prostate cancer. Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PRIMARY OBJECTIVES:
I. Evaluate the correlation of histopathology findings in comparison to regions of the prostate reported to be suspicious for harboring tumor burden on multiparametric MRI report/s.
II. Demonstration of the dosimetric and radiobiological advantages of focal stereotactic body radiation therapy (SBRT) versus whole-gland radiation therapy.
III. Evaluation of clinical outcomes in focal SBRT for localized prostate cancer.
OUTLINE:
Patients undergo 3 fractions of MRI-guided focal SRS every other day for 1 week. Patients undergo additional MRI scans between the 2nd and 3rd fractionated treatments, at 6 months following the end of radiation therapy, and at 12 and 24 months.
After completion of study treatment, patients are followed up every 3 months for up to 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (MRI-guided focal SRS) | Experimental | Patients undergo 3 fractions of MRI-guided focal SRS every other day for 1 week. Patients undergo additional MRI scans between the 2nd and 3rd fractionated treatments, at 6 months following the end of radiation therapy, and at 12 and 24 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stereotactic radiosurgery | Radiation | Undergo MRI-guided focal SRS |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with change in EPIC bowel domain score that was worse than 5 points | Number of patients with change in EPIC bowel domain score that was worse than 5 points A rate for the worse-than-5 point change in bowel score of up to 35% of patients will be considered acceptable, with a rate ≥55% specified as unacceptable | Up to 1 year from start of study |
| Number of patients with change in EPIC urinary domain score that was worse than 2 points | Number of patients with change in EPIC urinary domain score that was worse than 2 points A rate for the worse-than-2 point change in urinary score of up to 40% will be considered acceptable, with a rate ≥60% unacceptable | Up to 1 year from start of study |
| Measure | Description | Time Frame |
|---|---|---|
| PSA response | Number of patients with PSA failure. Failure occurs when the PSA is first noted to be 2 ng/mL or more than the patient's nadir value post radiation therapy completion | Up to 2 years from start of study |
| Number of acute gastrointestinal (GI) grade 3+ acute adverse events, evaluated by the Cancer Therapy Evaluation Program (CTEP) active version of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisha Fredman, MD | University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34604088 | Derived | Fredman E, Traughber B, Kharouta M, Podder T, Lo S, Ponsky L, MacLennan G, Paspulati R, Ellis B, Machtay M, Ellis R. Focal Prostate Stereotactic Body Radiation Therapy With Correlative Pathological and Radiographic-Based Treatment Planning. Front Oncol. 2021 Sep 15;11:744130. doi: 10.3389/fonc.2021.744130. eCollection 2021. |
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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 | Aug 4, 2020 |
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| magnetic resonance imaging |
| Device |
Undergo staging MRI with contrast |
|
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| quality-of-life assessment | Other | Quality of life scores will be summarized graphically and repeated measures of variance will be conducted to test for changes in scores over time |
|
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| Serum Prostate Antigen Test | Procedure | Test of the PSA protein in blood. The test will be run every three months for up to two years during the study. |
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| Digital Rectal Exam | Procedure | Exam of rectal health. Performed every three months for up to two years throughout the study. |
|
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| Expanded Prostate Cancer Index Composite | Behavioral | This survey measures a patient's function and bother after prostate cancer treatment. It will be analyzed using ANOVA using data collected every 6 months for up to 2 years of the study. |
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Defined as the first occurrence of worst severity of the adverse event =< 30 days after the completion of radiation therapy. Multivariate analysis will be used, and acute rates of GI toxicity will be reported with dose-volume histogram. |
| Up to 30 days after the completion of radiation therapy |
| Number of acute genitourinary (GU) grade 3+ acute adverse events, evaluated by the CTEP version of the NCI CTCAE | Defined as the first occurrence of worst severity of the adverse event =< 30 days after the completion of radiation therapy. | Up to 2 years from start of study |
| Number of late GI grade 3+ acute adverse events, evaluated by the CTEP version of the NCI CTCAE | Defined as the first occurrence of worst severity of adverse event > 180 days after radiation therapy completion. Multivariate analysis will be used, and acute rates of GI toxicity will be reported with dose-volume histogram. | Up to 2 years from start of study |
| Number of late GU grade 3+ acute adverse events, evaluated by the CTEP version of the NCI CTCAE | Defined as the first occurrence of worst severity of adverse event > 180 days after radiation therapy completion. | Up to 2 years from start of study |
| Number of patients with Disease-free survival | Defined as From the date of treatment to the date of documentation of disease progression or until the date of death from any cause. Radiographic efficacy will be summarized by calculating Kaplan-Meier curves. Also, 95% confidence intervals will be reported. Descriptive reports of Response Evaluation Criteria in Solid Tumors (RECIST) (1.1) and volumetric findings will be provided. | Up to 2 years from start of study |
| Time to local progression | Radiographic efficacy will be summarized by calculating Kaplan-Meier curves. Descriptive reports of RECIST (1.1) and volumetric findings will be provided. Time will be reported in months. | Up to 2 years from start of study |
| Time to distant failure | Radiographic efficacy will be summarized by calculating Kaplan-Meier curves. Descriptive reports of RECIST (1.1) and volumetric findings will be provided. Time will be reported in months. | Up to 2 years from start of study |
| Jun 1, 2022 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 13, 2020 | May 25, 2021 | 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 |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| D008279 | Magnetic Resonance Imaging |
| D017290 | Menogaril |
| D011788 | Quality of Life |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D009621 | Nogalamycin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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