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General Phone Number
888-844-8447
216-844-8447
Mailing Address
11100 Euclid Avenue
Cleveland, OH 44106
Trial Name:

S 9346
Intro: Intermediate Androgen Deprivation in Patients With Stage D2 Prostate
Condition:
Description: This study is designed around the use of combination hormone therapy with an LHRH analogue and an antiandrogen. Induction therapy consists of combined androgen deprivation for 8 cycles of treatment (7 months). Consolidation consists of a randomization to one of two treatment arms: continuous hormonal therapy or intermittent hormonal therapy. This study will assess whether patients randomized to the intermittent combined androgen therapy arm have survival that is not substantially worse than patients randomized to the continuous combined androgen therapy arm.
Criteria:
  1. Histologically or cytologically proven diagnosis of adenocarcinoma of the prostate
  2. Patients who have already begun the use of combined androgen deprivation therapy with LHRH agonist and antiandrogen may be eligible for late induction registration
  3. Registering institution must us the Hybritech or Abbott PSA assays
  4. Must have an elevated PSA > 5 ng/ml within 56 days prior to registration
  5. Patients with a history of prior neoadjuvant or adjuvant hormone therapy must have received four or less months of hormone treatment. Must not have received finasteride unless treatment was administered for nine months or less. All therapy must have been discontinued more than a year prior to registration
  6. Must not have had a bilateral orchiectomy
  7. Must not have acute cord compression
  8. Performance status 0-2 by SWOG criteria.
Contact: For Cancer Information, Current Clinical Trials, and Referral to a Physician please call (216) 844-5432 or (800) 641-2422

Participant Confidentiality:

All information regarding participation in Clinical Trials is treated with the utmost confidentiality. University Hospitals Case Medical Center and the Division of Clinical Research recognize and respect the confidentiality of this information. Access to information related to clinical trials and their participants is restricted to authorized clinical trials personnel only.

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