Clinical Trial Summary

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Phase

Phase 2/Phase 3

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Funding Agency/Sponsor

National Cooperative Group

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Disease

Prostate, Bladder, and Kidney Cancers

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Enrollment Eligibility

Inclusion Criteria:
- Patients post-prostatectomy with baseline Gleason >= 7 (per prostatectomy pathology)
and baseline PSA prior to the start of androgen deprivation therapy nadir >= 0.2 ng/ml
(post-operative value is never undetectable) obtained prior to step 1 registration
- Baseline testosterone level obtained post prostatectomy prior to the start of androgen
deprivation therapy and prior to step 1 registration
- Pathologically (histologically) proven diagnosis of adenocarcinoma of the prostate as
confirmed at time of prostatectomy; prostatectomy must have been performed =< 365 days
(1 year) prior to step 1 registration
- Primary treatment with radical prostatectomy
- Any type of radical prostatectomy is permitted, including retropubic, perineal,
laparoscopic or robotically assisted
- Prior ablative treatment for treatment of benign prostatic hypertrophy or focal
high-intensity focused ultrasound therapy (HIFU) prior to prostatectomy is allowed
- Prior androgen deprivation (luteinizing hormone-releasing hormone [LHRH] agonist
and/or non-steroidal anti-androgen) is allowed if discontinued at least 90 days prior
to study enrollment and given for =< 90 days duration prior to radical prostatectomy;
finasteride or dutasteride must be stopped before treatment but should not determine
eligibility; for patients on prior LHRH analogs, the discontinuation date should be
calculated based the expected duration of the sustained release injection, not simply
the injection date of the drug
- Pathologically proven to be lymph node negative by pelvic lymphadenectomy (pN0) or
lymph node status pathologically unknown (undissected pelvic lymph nodes [pNx])
- Any pT-stage based on American Joint Committee on Cancer 7th edition is acceptable for
study entry based on the following diagnostic workup:
- History/physical examination within 60 days prior to step 1 registration
- No distant metastases, based upon the following minimum diagnostic workup:
- A computed tomography (CT) scan of the abdomen and/or pelvis (with contrast if
renal function is acceptable; a CT without contrast is permitted if the patient
is not a candidate for contrast) or magnetic resonance imaging (MRI) of the
pelvis within 120 days prior to step 1 registration; lymph nodes will be
non-metastatic unless they measure more than 1.5 cm short axis;
- Bone scan within 120 days prior to step 1 registration (a sodium fluoride [NaF]
positron emission tomography/computed tomography [PET/CT] is an acceptable
substitute); if the bone scan is suspicious, a plain x-ray, CT scan, NaF PET/CT
and/or MRI must be obtained to rule out metastasis
- Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 within 90 days
prior to step 1 registration
- Platelets >= 1 X 10^6 cells/mm^3 (100,000) based upon complete 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 not allowed)
- Absolute neutrophil count greater than 1.5 x 10^9/L (1500)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 1.5 x the upper
limit of normal
- Total bilirubin normal unless history of Gilbert's syndrome
- The patient or a legally authorized representative must provide study-specific
informed consent prior to step 1 registration
- Available surgical formalin-fixed paraffin-embedded (FFPE) specimen for genomic
analysis on DECIPHER Genomic Resource Information Database (GRID) platform
Exclusion Criteria:
- Definitive clinical or radiologic evidence of metastatic disease
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
for a minimum of 2 years) Ta bladder cancer is not considered invasive
- Prior radiotherapy to the region of the study cancer that would result in overlap of
radiation therapy fields
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a
different cancer is allowable if completed more than two years prior to step 1
registration; prior androgen deprivation is allowed
- Prior whole gland ablative therapy (i.e. cryoablation or high intensity focused
ultrasound [HIFU]) for prostate cancer is allowed; prior focal HIFU or treatment for
benign prostatic hypertrophy is allowed
- Prostatectomy performed greater than 365 days (1 year) prior to step 1 registration
- Severe and/or active co-morbidity defined as follows:
- History of inflammatory bowel disease
- History of active 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 step 1 registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization within 15 days of step 1 registration or precluding
study therapy at the time of step 1 registration
- Uncontrolled severe illness or medical condition (including uncontrolled
diabetes), which in the judgment of the treating physician would make the
administration of chemotherapy inadvisable
- Concurrent or planned treatment with strong inhibitors (e.g. ketoconazole,
clarithromycin, etcetera [etc]) or strong inducers (e.g. carbamazepine,
phenytoin, rifampin, phenobarbital, efavirenz, tipranavir, St. John's wort) of
cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who
are already on these treatments)
- Human immunodeficiency virus (HIV) positive with cluster of differentiation 4 (CD4)
count < 200 cells/microliter; note that patients who are HIV positive are eligible,
provided they are under treatment with highly active antiretroviral therapy (HAART)
and have a CD4 count >= 200 cells/microliter within 30 days prior to step 1
registration; note also that HIV testing is not required for eligibility for this
protocol

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