Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill
tumor cells and shrink tumors. Androgens can cause the growth of prostate cancer cells.
Androgen-deprivation therapy may lessen the amount of androgens made by the body. It is not
yet known whether radiation therapy is more effective with or without androgen-deprivation
therapy in treating patients with prostate cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it
works compared with radiation therapy given together with androgen-deprivation therapy in
treating patients with prostate cancer.
Phase
Phase 3
Funding Agency/Sponsor
National Cooperative Group
Disease
Prostate, Bladder, and Kidney Cancers
Enrollment Eligibility
Inclusion Criteria:
1. Pathologically (histologically) proven diagnosis of prostatic adenocarcinoma, at
intermediate risk for recurrence, within 180 days prior to registration as determined
by having one or more of the following intermediate-risk features: Gleason score 7;
prostate-specific antigen (PSA) >10 but ≤20; clinical stage T2b-T2c.
- Patients previously diagnosed with low risk (Gleason score ≤ 6, clinical stage <
T2a, and PSA < 10) prostate cancer undergoing active surveillance who are
re-biopsied and found to have intermediate risk disease according to the protocol
criteria are eligible for enrollment within 180 days of the repeat biopsy
procedure.
2. Clinically negative lymph nodes as established by imaging (pelvic +/- abdominal CT or
MRI), nodal sampling, or dissection within 60 days prior to registration, except as
noted immediately below:
- Patients with a single intermediate risk factor only do not require
abdominopelvic imaging, but these studies may be obtained at the discretion of
the treating physician. Patients with 2 or 3 risk factors are required to undergo
pelvic +/- abdominal CT or MRI.
- Patients with lymph nodes equivocal or questionable by imaging are eligible
without biopsy if the nodes are ≤1.5 cm; any node larger than this on imaging
will require negative biopsy for eligibility.
3. No evidence of bone metastases (M0) on bone scan within 60 days prior to registration.
- Bone scan is not required for patients enrolled with a single intermediate risk
factor only, but this scan may be obtained at the discretion of the treating
physician. Patients with 2 or 3 risk factors will require a negative bone scan
for eligibility.
- Equivocal bone scan findings are allowed if plain film x-rays are negative for
metastasis.
4. History/physical examination (to include, at a minimum, digital rectal examination of
the prostate and examination of the skeletal system and abdomen, and formal
comorbidity assessment via the ACE-27 instrument) within 60 days prior to
registration.
5. Zubrod Performance Status 0-1
6. Age ≥ 18
7. Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott,
Hybritech) within 60 days prior to registration
- Study entry PSA must not be obtained during the following time frames: (1) 10-day
period following prostate biopsy; (2) following initiation of ADT; (3) within 30
days after discontinuation of finasteride; or (4) within 90 days after
discontinuation of dutasteride.
8. For patients undergoing brachytherapy only: complete blood count (CBC)/differential
obtained within 60 days prior to registration, with adequate bone marrow function
defined as follows:
- Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3
- Platelets ≥ 100,000 cells/mm3
- Hemoglobin (Hgb) ≥ 8.0 g/dl (Note: The use of transfusion or other intervention
to achieve Hgb ≥ 8.0 g/dl is acceptable.)
9. Patient must be able to provide study-specific informed consent prior to study entry.
Exclusion Criteria:
1. Patients with Gleason Score ≥ 8; PSA > 20; OR Clinical Stage ≥ T3 are ineligible for
this trial.
- Should findings of extracapsular extension or seminal vesicle invasion be noted
on prostate MRI, this study, if used, will not render patients ineligible for
accrual to this protocol. Primary tumor staging for eligibility purposes is to be
based on palpable or core biopsy evidence only with respect to extracapsular
extension or seminal vesicle involvement.
2. Patients with all three intermediate risk factors who also have ≥ 50% of the number of
their biopsy cores positive for cancer are ineligible for this trial.
3. Prior invasive malignancy (except non-melanomatous skin cancer) or hematological
(e.g., leukemia, lymphoma, myeloma) malignancy unless disease free for a minimum of 5
years (prior diagnoses of carcinoma in situ are permitted)
4. Prior radical surgery (prostatectomy), high-intensity focused ultrasound (HIFU) or
cryosurgery for prostate cancer
5. Prior hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide),
antiandrogens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or bilateral
orchiectomy
6. Use of finasteride within 30 days prior to registration
7. Use of dutasteride within 90 days prior to registration
8. Prior or concurrent cytotoxic chemotherapy for prostate cancer; prior chemotherapy for
a different cancer is permitted.
9. Prior RT, including brachytherapy, to the region of the study cancer that would result
in overlap of RT fields
- Any patient undergoing brachytherapy must have transrectal ultrasound
confirmation of prostate volume <60 cc, American Urological Association Symptom
Index (AUA-SI) score ≤15 within 60 days of registration, and no history of prior
transurethral resection of the prostate (TURP); prior TURP is permitted for
patients who receive EBRT only)
10. 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 registration
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy within 30 days before
registration
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;
note, however, that laboratory tests for liver function and 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 HIV testing is not
required for entry into this protocol. While the treatment employed in this study
is not significantly immunosuppressive, it is felt that a diagnosis of AIDS
associated with prostate cancer is likely to impact this study's primary endpoint
of overall survival. Patients who are HIV seropositive but do not meet criteria
for diagnosis of AIDS are eligible for study participation.
11. Men who are sexually active with a woman of child-bearing potential and not
willing/able to use medically acceptable forms of contraception (e.g., surgical,
barrier, medicinal) during protocol treatment and during the first 3 months after
cessation of protocol treatment; this exclusion is necessary because the treatment
involved in this study may be significantly teratogenic.