A PHASE III PROSPECTIVE RANDOMIZED TRIAL OF DOSE-ESCALATEDRADIOTHERAPY WITH OR WITHOUT SHORT-TERM ANDROGEN DEPRIVATIONTHERAPY FOR PATIENTS WITH INTERMEDIATE-RISK PROSTATE CANCER - RTOG 0815
- Conditions
- intermediate risk prostate cancerMedDRA version: 12.1Level: LLTClassification code 10026389Term: Malignant neoplasm of prostate
- Registration Number
- EUCTR2010-020825-42-IE
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 1520
3.1.1 Pathologically (histologically) proven diagnosis of prostatic adenocarcinoma within 6 months
prior to registration at intermediate risk for recurrence as determined by having one or more of
the following intermediate-risk features: Gleason Score 7; PSA >10 but =20; Clinical Stage T2b-
T2c.
3.1.2 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:
3.1.2.1 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.
3.1.2.2 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.
3.1.3 No evidence of bone metastases (M0) on bone scan within 60 days prior to registration.
3.1.3.1 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.
3.1.3.2 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) within 60 days prior to registration. Note: The ACE-27
is posted on the RTOG website, next to the protocol.
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
3.1.7.1 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 CBC/differential obtained within 60 days prior to registration (for patients undergoing
brachytherapy only), with adequate bone marrow function defined as follows:
3.1.8.1 Absolute neutrophil count (ANC) = 1,800 cells/mm3
3.1.8.2 Platelets = 100,000 cells/mm3
3.1.8.3 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
3.2.1 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.
3.2.2 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)
3.2.3 Prior radical surgery (prostatectomy), high-intensity focused ultrasound (HIFU) or cryosurgery
for prostate cancer
3.2.4 Prior hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide), antiandrogens
(e.g., flutamide, bicalutamide), estrogens (e.g., DES), or bilateral orchiectomy
3.2.5 Use of finasteride within 30 days prior to registration
3.2.6 Use of dutasteride within 90 days prior to registration
3.2.7 Prior or concurrent cytotoxic chemotherapy for prostate cancer; prior chemotherapy for a
different cancer is permitted.
3.2.8 Prior RT, including brachytherapy, to the region of the study cancer that would result in overlap
of RT fields
3.2.8.1 Any patient undergoing brachytherapy must have transrectal ultrasound confirmation of
prostate volume <60 cc, AUA 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)
3.2.9 Severe, active co-morbidity, defined as follows:
3.2.9.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 6
months
3.2.9.2 Transmural myocardial infarction within the last 6 months
3.2.9.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
3.2.9.4 Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring
hospitalization or precluding study therapy within 30 days before registration
3.2.9.5 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.
3.2.9.6 Acquired Immune Deficiency Syndrome (AIDS) based upon current 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.
3.2.10 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method