Hypofractionated Radiation Therapy or Conventional Radiation Therapy After Surgery in Treating Patients With Prostate Cancer
Condition: Prostate Adenocarcinoma; Stage I Prostate Adenocarcinoma; Stage II Prostate Adenocarcinoma; Stage III Prostate Adenocarcinoma
MeSH terms: Adenocarcinoma; Prostatic Neoplasms
Intervention: Hypofractionated radiation therapy; Conventional radiation therapy; Optional androgen deprivation therapy
Intervention description: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity.; 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity.; Any luteinizing hormone-releasing hormone (LHRH) agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.
Intervention MeSH terms: Androgens
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 296.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial studies how well hypofractionated radiation therapy works
      compared to conventional radiation therapy after surgery in treating patients with prostate
      cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a
      shorter period of time and may kill more tumor cells and have fewer side effects.
      Conventional radiation therapy uses high energy x-rays, gamma rays, neutrons, protons, or
      other sources to kill tumor cells and shrink tumors. It is not yet known whether giving
      hypofractionated radiation therapy or conventional radiation therapy after surgery may work
      better in treating patients with prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  PRIOR TO STEP 1 REGISTRATION

          -  Adenocarcinoma of the prostate treated primarily with radical prostatectomy

               -  Any type of radical prostatectomy will be permitted, including retropubic,
                  perineal, laparoscopic, or robotically assisted; there is no time limit for the
                  date of radical prostatectomy

          -  One of the following pathologic T-classifications: pT2 or pT3

               -  Patients with positive surgical margins are eligible

          -  One of the following pathologic N-classifications: pN0, pNX

               -  If a lymph node dissection is performed, the number of lymph nodes removed per
                  side of the pelvis and the extent of the pelvic lymph node dissection (obturator
                  versus (vs.) extended lymph node dissection) should be noted whenever possible

          -  No clinical evidence of regional lymph node metastasis

               -  Computed tomography (CT) (with contrast if renal function is acceptable; a
                  noncontrast CT is permitted if the patient is not a candidate for contrast),
                  magnetic resonance imaging (MRI), nodal sampling, or dissection of the pelvis
                  within 120 days prior to step 1 registration

               -  Patients with pelvic lymph nodes equivocal or questionable by imaging are
                  eligible if the nodes are =< 1 cm in the short axis

          -  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

               -  Patients with equivocal or questionable DRE findings should have an MRI of the
                  pelvis to exclude the presence of a prostate fossa mass

               -  Patients with equivocal or questionable exam findings by DRE or MRI are eligible
                  if a biopsy of the lesion is negative for tumor

          -  No evidence of bone metastases (M0) on bone scan (Na F positron emission tomography
             (PET)/CT is an acceptable substitute) within 120 days prior to step 1 registration

               -  Equivocal bone scan findings are allowed if plain films and/or MRI are negative
                  for metastasis

          -  Zubrod performance status 0-1 within 60 days prior to step 1 registration

          -  The patient or a legally authorized representative must provide study-specific
             informed consent prior to step 1 registration

          -  Willingness and ability to complete the Expanded Prostate Cancer Index Composite
             (EPIC-26) questionnaire

          -  Only English and French-speaking patients are eligible to participate

          -  PRIOR TO STEP 2 REGISTRATION

          -  The EPIC-26 must be completed in full and entered within 10 business days after step 1
             registration; NRG Oncology Statistical and Data Management Center has 3 business days
             to score the results and send a notification to the site to proceed to step 2
             randomization

        Exclusion Criteria:

          -  A post-prostatectomy PSA nadir >= 0.2 ng/mL AND Gleason >= 7

          -  pT2 with a negative surgical margin and PSA < 0.1 ng/mL

          -  Androgen deprivation therapy started prior to prostatectomy for > 6 months (180 days)
             duration;

               -  Note: The use of finasteride or dutasteride (? tamsulosin) for longer periods
                  prior to prostatectomy is acceptable

          -  Androgen deprivation therapy started after prostatectomy and prior to step 1
             registration for > 6 weeks (42 days)

          -  Neoadjuvant chemotherapy before or after prostatectomy

          -  Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a
             minimum of 3 years and not in the pelvis; (for example, carcinoma in situ of the oral
             cavity is permissible if disease free for a minimum of 3 years; however, patients with
             prior history of bladder cancer are not allowed no matter the disease free duration);
             prior hematological (e.g., leukemia, lymphoma, myeloma) malignancy is not allowed

          -  Previous chemotherapy for any other disease site if given within 3 years prior to step
             1

          -  Prior radiotherapy, including brachytherapy, to the region of the study cancer that
             would result in overlap of radiation therapy treatment volumes

          -  Severe, active co-morbidity, defined as follows:

               -  Unstable angina and/or congestive heart failure requiring hospitalization within
                  the last 6 months

               -  Transmural myocardial infarction within the last 6 months

               -  Acute bacterial or fungal infection requiring intravenous antibiotics at the time
                  of step 1 registration

               -  Chronic obstructive pulmonary disease exacerbation or other respiratory illness
                  requiring hospitalization or precluding study therapy at the time of step 1
                  registration

               -  Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic
                  disease

               -  Human immunodeficiency virus (HIV) positive with CD4 count < 200
                  cells/microliter; note that patients who are HIV positive are eligible, provided
                  they are under treatment with highly active antiretroviral therapy (HAART) and
                  have a CD4 count >= 200 cells/microliter within 30 days prior to registration;
                  note also that HIV testing is not required for eligibility for this protocol

               -  End-stage renal disease (ie, on dialysis or dialysis has been recommended)

          -  Prior allergic reaction to the study drugs involved in this protocol

          -  History of inflammatory bowel disease, prior bowel surgeries (or colostomy) for any
             reason, or prior partial/radical cystectomy for any reason