In this study, prostate cancer patients whose cancer has not spread to the lymph nodes will receive radiation therapy targeted to the prostate and nearby tissues with or without whole pelvis radiation therapy. PSMA imaging will be used to visualize prostate cancer prior to starting the trial.
The current treatment of high risk and very high risk localized prostate cancer is by radiation therapy (RT) and hormone therapy (ADT). RT uses radiation to kill the cancer cells while hormone therapy lowers the levels of male hormones like testosterone, which the cancer needs to grow. Radiation is targeted to the prostate and nearby tissues, which may or may not include whole pelvis radiation therapy (WPRT). The benefit of whole pelvis radiation therapy is not well understood. Therefore, clinical research is needed to assess the benefits/risks of whole pelvis radiation therapy in prostate cancer treatment. In addition to traditional cancer imaging methods like CT, MRI, and bone scan, new techniques like PSMA imaging are now available to examine prostate cancer. The PSMA scan involves a small amount of radioactive tracer (18F-PSMA-1007) being injected into the vein, which marks the prostate cancer cells for better visualization of the cancer location and spread. Because of its higher accuracy, results of PSMA scans can change how doctors plan cancer treatment, like where they aim radiation and how much they use. In this study, prostate cancer patients whose cancer has not spread to the lymph nodes will receive radiation therapy. PSMA imaging will be used to visualize prostate cancer prior to starting the trial. There will be two treatment groups (1) Prostate Only Radiation Therapy (PORT), and Prostate + Whole Pelvis Radiation Therapy (P-WPRT), and all participants will receive hormone therapy as part of standard of care. In addition to comparing the biochemical failure free survival (BFFS) between the two treatment groups, the study will also compare distant metastases free survival (DMFS), toxicity, patient reported outcomes and overall survival (OS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
6800cGy in 25 daily fractions to the prostate and surrounding tissues
6800cGy to the prostate and surrounding tissues + 5000cGy to the whole pelvis in 25 daily fractions.
Cross Cancer Institute
Edmonton, Alberta, Canada
5-year Biochemical Failure Free Survival (BFFS)
As measured from the date of randomization to the first recorded date of biochemical failure as defined by serum PSA exceeding nadir PSA +2 ng/mL.
Time frame: Number of events as measured from the date of randomization to 5-years.
Distant metastases-free survival (DMFS)
Calculated from the time of randomization until the development of first distant metastasis outside the pelvic nodal regions. Patients will be censored at either the date of last follow-up or date of death.
Time frame: As measured from the date of randomization until the development of first distant metastasis outside the pelvic nodal regions or date of death from any cause, whichever came first; assessed up to 10 years (end of extended follow-up)
Acute and late toxicity as per CTCAE 5.0
Patient toxicity will be documented as per the domains of the CTCAE v5.0.
Time frame: Acute toxicity will be measured up to the 90 days post-radiation, and late toxicity will be monitored over the course of the study follow-up, up to 5 years post-radiation.
Overall survival
As measured form the time of randomization to the time of death from any cause.
Time frame: As measured form the time of randomization to date of death from any cause, assessed up to 10 years (end of extended follow-up)
Patient reported outcomes: IPSS
International Prostate Symptom Score (IPSS) is a standardized questionnaire used worldwide to assess the severity of urinary symptoms. It consists of 7 questions, each scored from 0 (no symptoms) to 5 (most severe symptoms). The total score is the sum of all responses, giving a range from 0 to 35
Time frame: Outcomes will be measured from the completion of radiation up to 90 days post-radiation, and over the course of the study follow-up, up to 5 years post-radiation.
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Patient reported outcomes: EQ-5D
The 5-item EQ-5D index score will be transformed into a utility score between 0, "Worst health state," and 1, "Best health state." The index score or the cost-utility equation can be used in the quality adjusted survival analysis. For this study, the plan is to report the multidimensional utilities for comparative purposes.
Time frame: Outcomes will be measured from the completion of radiation up to 90 days post-radiation, and over the course of the study follow-up, up to 5 years post-radiation.
Patient reported outcomes: EPIC-26
Expanded Prostate Cancer Index Composite - Short Form (EPIC-26) uses a 0-100 scale per domain, where 0 means worst function and 100 means best function. EPIC-26 overall score will be reported, as well as intra-individual change from baseline. Score changes will also be stratified by clinically minimally important differences of 5 for bowel and hormonal, 7 for urinary, and 10 for sexual domain
Time frame: Outcomes will be measured from the completion of radiation up to 90 days post-radiation, and over the course of the study follow-up, up to 5 years post-radiation.