RTOG 815 PHASE III PROSPECTIVE RANDOMIZED TRIAL OF DOSE-ESCALATED RADIOTHERAPY WITH OR WITHOUT SHORT-TERM ANDROGEN DEPRIVATION THERAPY FOR PATIENTS WITH INTERMEDIATE-RISK PROSTATE CANCER
This current RTOG phase III, prospective, randomized trial is designed primarily to define the
magnitude of benefit for adding ADT to dose-escalated RT specifically in the treatment of
intermediate-risk prostate cancer. The study will allow this to be accomplished on several levels.
For purposes of eligibility for this particular study, 3 intermediate-risk features have been
identified: T2b-T2c disease, PSA and amp;gt;10 but ≤20, and Gleason score of 7. One or more of these risk
features associated with a newly diagnosed prostate cancer connotes clinicopathologic eligibility
for this study. Patients with all 3 of these risk factors who additionally present with ≥ 50% of their
sampled biopsy cores positive are believed to be at high risk for systemic progression and are
excluded from this study
3.1 Conditions for Patient Eligibility (12/10/10)
3.1.1 Pathologically (histologically) proven diagnosis of prostatic adenocarcinoma, at intermediate
risk for recurrence, within 180days prior to registration as determined by having one or more of
the following intermediate-risk features: Gleason Score 7; PSA >10 but ≤20; Clinical Stage T2b-
188.8.131.52 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.
3.1.2 Clinically negative lymph nodes as established by imaging (pelvic +/- abdominal CT or MRI),
nodal sampling, or dissection prior to registration, except as noted immediately
184.108.40.206 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.
220.127.116.11 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
3.1.3 No evidence of bone metastases (M0) on bone scan prior to registration.
18.104.22.168 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.
22.214.171.124 Equivocal bone scan findings are allowed if plain film x-rays are negative for metastasis.
3.1.4 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)prior to registration. Note: The ACE-27
is posted on the RTOG website, next to the protocol. Institutions may access a web-based
Comorbidity Calculator at http://oto2.wustl.edu/clinepi/comorbid.html.
3.1.5 Zubrod Performance Status 0-1
3.1.6 Age ≥ 18
3.1.7 Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech)
within 60 days prior to registration
126.96.36.199 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.
3.1.8 For patients undergoing brachytherapy only: CBC/differential obtained within 60 days prior to
registration, with adequate bone marrow function defined as follows:
188.8.131.52 Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3
184.108.40.206 Platelets ≥ 100,000 cells/mm3
220.127.116.11 Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥
8.0 g/dl is acceptable.)
3.1.9 Patient must be able to provide study-specific informed consent prior to study entry.