| Trial Name: |
SANO 1805
|
| Intro: |
A Multicenter, open-label, randomized, Phase III Trial comparing Immediate Adjuvant Hormonal Therapy (ELIGARD®- leuprolide acetate) in combination with TAXOTERE® (docetaxel) administered every three weeks versus Hormonal Therapy alone versus Deferred Therapy followed by the
same therapeutic options in patients with Prostate Cancer at High Risk of Relapse after Radical Prostatectomy |
| Condition: |
|
| Description: |
This study aims to determine the long-term survival of patients. In addition, the objective of the study is also to compare if the combination of Taxotere® (a chemotherapy drug) with Eligard® (hormonal therapy) is more efficient than and as safe as Eligard® alone. Patients will receive, either around 2 months after surgery or later, 6 courses of chemotherapy with Taxotere® and 6 courses of hormone therapy with Eligard® or 6 courses of Eligard® only. |
| Criteria: |
- Pathologically confirmed adenocarcinoma of the prostate based on central pathology review
- Patients have undergone a radical prostatectomy
- No bone or lung metastases
- No prior systemic treatment for prostate cancer with hormonal therapy, chemotherapy or any other anticancer treatment. No prior radiation
- Serum testosterone > 150 ng/dL 6. ECOG performance status ≤1
- Age ≥ 18 years
- Patients must have normal bone marrow, liver and kidney function.
|
| 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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