Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
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.
Phase
Phase 3
Funding Agency/Sponsor
National Cooperative Group
Disease
Prostate, Bladder, and Kidney Cancers
Enrollment Eligibility
Inclusion Criteria:
1. 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 (undissected pelvic lymph nodes [Nx]), i.e.
lymph node dissection is not required;
• 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.
2. A post-radical prostatectomy entry prostate-specific antigen (PSA) of ≥ 0.1 and < 2.0
ng/mL at least 6 weeks (45 days) after prostatectomy and within 30 days of
registration;
3. One of the following pathologic classifications:
- T3N0/Nx disease with or without a positive prostatectomy surgical margin; or
- T2N0/Nx disease with or without a positive prostatectomy surgical margin;
4. Prostatectomy Gleason score of 9 or less;
5. Zubrod Performance Status of 0-1;
6. Age ≥ 18;
7. No distant metastases, based upon the following minimum diagnostic workup:
- History/physical examination (including digital rectal exam) within 8 weeks (60
days) prior to registration;
- A computerized tomography (CT) scan of the pelvis (with contrast if renal
function is acceptable; a noncontrast CT is permitted if the patient is not a
candidate for contrast) or magnetic resonance imaging (MRI) of the pelvis within
120 days prior to registration;
- Bone scan within 120 days prior to registration; if the bone scan is suspicious,
a plain x-ray and/or MRI must be obtained to rule out metastasis.
8. Adequate bone marrow function, within 90 days prior to registration, defined as
follows:
- Platelets ≥ 100,000 cells/mm^3 based upon compete blood count (CBC);
- Hemoglobin ≥ 10.0 g/dl based upon CBC (Note: The use of transfusion or other
intervention to achieve Hgb ≥ 10.0 g/dl is recommended).
9. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2 x the upper
limit of normal within 90 days prior to registration;
10. Serum total testosterone must be ≥ 40% of the lower limit of normal (LLN) of the assay
used (testosterone ÷ LLN must be ≥ 0.40) within 90 days prior to registration (Note:
Patients who have had a unilateral orchiectomy are eligible as long as this
requirement is met);
11. Patients must sign a study-specific informed consent prior to study entry.
Exclusion Criteria:
1. A palpable prostatic fossa abnormality/mass suggestive of recurrence, unless shown by
biopsy under ultrasound guidance not to contain cancer;
2. 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 sampled and is negative;
3. 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;
4. Androgen deprivation therapy started after prostatectomy and prior to registration
(Note: The use of finasteride or dutasteride (±tamsulosin) after prostatectomy is not
acceptable - must be stopped within 3 months after prostatectomy. Androgen deprivation
therapy must be stopped within 3 months after prostatectomy);
5. Neoadjuvant chemotherapy before or after prostatectomy;
6. Prior chemotherapy for any other disease site if given within 5 years prior to
registration;
7. Prior cryosurgery or brachytherapy of the prostate; prostatectomy should be the
primary treatment and not a salvage procedure;
8. Prior pelvic radiotherapy;
9. Prior invasive malignancy (except non-melanomatous skin cancer) or superficial bladder
cancer unless disease free for a minimum of 5 years [for example, carcinoma in situ of
the oral cavity is permissible];
10. Severe, active co-morbidity, defined as follows:
- History of inflammatory bowel disease;
- History of hepatitis B or C; Blood tests are not required to determine if the
patient has had hepatitis B or C, unless the patient reports a history of
hepatitis.
- 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 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;
AST or ALT are required; note, however, that laboratory tests for coagulation
parameters are not required for entry into this protocol.
- Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease
Control and Prevention (CDC) definition; Note, however, that human
immunodeficiency viruses (HIV) testing is not required for entry into this
protocol. The need to exclude patients with acquired immunodeficiency syndrome
(AIDS) from this protocol is necessary because the treatments involved in this
protocol may result in increased toxicity and immunosuppression.
11. Prior allergic reaction to the study drug(s) involved in this protocol.