Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation
therapy to see how well it works compared with antiandrogen therapy and radiation therapy
alone in treating patients with prostate cancer that has been removed by surgery. Androgen
can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen
made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink
tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the
growth of tumor cells, either by killing the cells, by stopping them from dividing, or by
stopping them from spreading. Giving antiandrogen therapy and radiation therapy with or
without docetaxel after surgery may kill any remaining tumor cells.
Phase
Phase 2/Phase 3
Funding Agency/Sponsor
National Cooperative Group
Disease
Prostate, Bladder, and Kidney Cancers
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