Adjuvant Androgen Suppression Plus Radiation Therapy for High-Risk Localized Adenocarcinoma Prostate

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byTamim Niazi, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: McGill University

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No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

To evaluate the efficacy of LHRH agonist with adjuvant pelvic radiation therapy in post radical prostatectomy patients with high risk pathological features for failure. To determine the freedom from biochemical (maintenance of a PSA less than nadir + 2 ng/ml) and clinical progression rate at 5 years.

Eligibility Criteria

Inclusion Criteria

Adequate bone marrow function, within 90 days prior to registration, defined as follows: Platelets ≥ 100,000 cells/mm3 based upon CBC; Hemoglobin ≥ 10.0 g/dl based upon CBC AST or ALT < 2 x the upper limit of normal within 90 days prior to registration; Patients must sign a study-specific informed consent prior to study entry.

You can have had surgery to remove your prostate, no matter how it was done. If you had lymph nodes removed during the surgery, the details will be recorded. There is no limit on when the surgery was performed.

Adenocarcinoma of the prostate treated primarily with radical prostatectomy, pathologically proven to be lymph node negative by pelvic lymphadenectomy (N0) or lymph node status pathologically unknown (undissected pelvic lymph nodes [Nx]), i.e. lymph node dissection is not required;

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Exclusion Criteria

A palpable prostatic fossa abnormality/mass suggestive of recurrence, unless shown by biopsy under ultrasound guidance not to contain cancer;

Severe, active co-morbidity, defined as follows: History of inflammatory bowel disease; History of 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 registration; Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; AST or ALT are required; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol.

N1 patients are ineligible, as are those with pelvic lymph node enlargement ≥ 1.5 cm in greatest dimension by CT scan or MRI of the pelvis, unless the enlarged lymph node is sampled and is negative;

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