Trial Search Results

Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide, and luteinizing hormone-releasing hormone agonist, may lessen the amount of androgens made by the body. It is not yet known which regimen of radiation therapy with or without androgen-deprivation therapy is more effective for prostate cancer.

PURPOSE: This randomized phase III trial is studying prostate radiation therapy to see how well it works compared with short-term androgen deprivation therapy given together with pelvic lymph node radiation therapy with or without prostate radiation therapy in treating patients with a rising PSA after surgery for prostate cancer.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Radiation Therapy Oncology Group

Collaborator: NRG Oncology

Stanford Investigator(s):

Intervention(s):

  • Drug: bicalutamide
  • Drug: flutamide
  • Radiation: radiation therapy

Phase:

Phase 3

Eligibility


DISEASE CHARACTERISTICS:

   - Adenocarcinoma of the prostate treated primarily with radical prostatectomy

      - Pathologically proven to be lymph node-negative by pelvic lymphadenectomy (N0) or
      lymph node status pathologically unknown (Nx [undissected pelvic lymph nodes
      because lymph node dissection is not required])

      - Any type of radical prostatectomy allowed, including retropubic, perineal,
      laparoscopic, or robotically assisted

      - Meets 1 of the following pathologic classifications:

         - T3 N0/Nx disease with or without positive prostatectomy margins

         - T2 N0/Nx disease with or without positive prostatectomy margins

      - N1 patients are ineligible, as are those with pelvic lymph node enlargement ≥ 1.5
      cm in greatest dimension by CT scan or MRI of the pelvis, unless the enlarged
      lymph node is negative

      - Prostatectomy Gleason score of 9 or less

   - A post-radical prostatectomy entry PSA of ≥ 0.1 and ≤ 1.0 ng/mL at least 6 weeks after
   prostatectomy and within 30 days of registration

   - Serum total testosterone ≥ 40% of the lower limit of normal (patients who have had a
   unilateral orchiectomy are eligible as long as this requirement is met)

   - No distant metastases based on history/physical examination, CT scan or MRI of the
   abdomen and pelvis, and bone scan

   - No palpable prostatic fossa abnormality/mass suggestive of recurrence, unless shown by
   biopsy under ultrasound guidance not to contain cancer

PATIENT CHARACTERISTICS:

   - Zubrod performance status 0-1

   - Platelets ≥ 100,000/mm^3

   - Hemoglobin ≥ 10.0 g/dL (the use of transfusion or other intervention to achieve this
   is allowed)

   - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2 x upper limit
   of normal

   - No prior invasive malignancy (except nonmelanoma skin cancer) or superficial bladder
   cancer unless disease free for a minimum of 5 years (e.g., carcinoma in situ of the
   oral cavity is permissible)

   - No severe, active co-morbidity, including any of the following:

      - History of inflammatory bowel disease

      - History of hepatitis B or C

      - Unstable angina and/or congestive heart failure requiring hospitalization within
      the past 6 months

      - Transmural myocardial infarction within the past 6 months

      - Acute bacterial or fungal infection requiring intravenous antibiotics at the time
      of registration

      - Chronic obstructive pulmonary disease exacerbation or other respiratory illness
      requiring hospitalization or precluding study therapy at the time of registration

      - Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

      - Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease
      Control (CDC) definition

         - HIV testing is not required for entry

   - No prior allergic reaction to the study drug(s) involved in this protocol

PRIOR CONCURRENT THERAPY:

   - See Disease Characteristics

   - More than 5 years since prior chemotherapy for any other disease site

   - No androgen-deprivation therapy started prior to prostatectomy for > 6 months duration

      - The use of finasteride or dutasteride (± tamsulosin) for longer periods prior to
      prostatectomy is acceptable

   - No androgen-deprivation therapy started after prostatectomy and prior to registration

      - The use of finasteride or dutasteride (± tamsulosin) after prostatectomy is not
      acceptable, it must be stopped within 3 months after prostatectomy

   - No neoadjuvant chemotherapy before or after prostatectomy

   - No prior cryosurgery or brachytherapy of the prostate (prostatectomy should be the
   primary treatment and not a salvage procedure)

   - No prior pelvic radiotherapy

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Male

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting