Gender
Male
Age Group
18 Years and up
Accepting Healthy Volunteers
No
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.