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Protocol No. NRGGU003

Principal Investigator Ritter, Mark

Phase III

Age Group Adult

Scope National

Sponsor Type National

Title A Randomized Phase III Trial of Hypofractionated Post-Prostatectomy Radiation Therapy (HYPORT) versus Conventional Post Prostatectomy Radiation Therapy (COPORT)

Objective The purpose of this study is to compare any good and bad effects of using radiation therapy at a higher dose given with each radiation treatment (fraction) for a shorter length of time, called hypofractionated radiation therapy, to radiation therapy given for the standard length of time. The study will compare side effects of the study radiation given at a higher dose for a shorter length of time with those of the usual radiation treatment. The study will also compare how well the cancer is controlled between the two treatments. This study will allow the researchers to know whether this study approach is the same or worse than the usual approach. The study approach is considered the experimental treatment in this study.

Treatment This study has two study groups. Group 1 will get radiation therapy for the usual length of time (7 weeks) at the usual radiation dose with each treatment (fraction). People in Group 1 also may receive hormone therapy if their doctor recommends for up to 6 months. Group 2 will get radiation therapy for a shorter length of time (5 weeks) at a higher radiation dose with each treatment (fraction). People in Group 2 also may receive hormone therapy if their doctor recommends for up to 6 months.

Description A computer will by chance assign you to a treatment group in the study. This is called randomization. This is done by chance because no one knows if one study group is better or worse than the other. Neither you nor your doctor can choose which group you will be in. You will have an equal chance of being placed in either group .You will receive the study treatment for about 7 weeks if you are in Group 1 and for 5 weeks if you are in Group 2. If your doctor recommends hormone therapy, you will receive the hormone therapy for up to 6 months. After you finish the study treatment, your doctor will continue to watch you for side effects and follow your condition indefinitely.

Key Eligibility
  • Adenocarcinoma of the prostate treated primarily with radical prostatectomy
  • One of the following pathologic T-classifications: pT2 or pT3
  • One of the following pathologic N-classifications: pN0, pNX
  • No clinical evidence of regional lymph node metastasis
  • A post-radical prostatectomy study entry PSA ≥45 days after prostatectomy and within 30 days prior to Step 1, < 2.0 ng/mL
  • No evidence of a local recurrence in the prostate fossa based on a digital rectal examination (DRE) within 60 days prior to Step 1 registration
  • No evidence of bone metastases (M0) on bone scan
  • Only English and French-speaking patients are eligible to participate as these are the only language the Expanded Prostate Cancer Index Composite (EPIC) questionnaire has been validated in
  • If androgen deprivation therapy started after prostatectomy and prior to Step 1 registration for > 6 weeks, patients will be excluded
  • Patients who had neoadjuvant chemotherapy before or after prostatectomy will be excluded
  • Patients with previous chemotherapy for any other disease site if given within 3 years prior to Step 1 are excluded
  • Patients with prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy treatment volumes are excluded
  • Patients with a history of inflammatory bowel disease, prior bowel surgeries (or colostomy) for any reason, or prior partial/radical cystectomy for any reason are excluded

Applicable Disease Sites Prostate

Therapies Involved Radiotherapy

Status Open

Participating Institutions Aspirus UW Cancer Center (formerly Riverview Hospital); Johnson Creek, UW Cancer Center; Swedish American Hospital, Rockford ; UW Hospital and Clinics