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NCT00004124 · ClinicalTrials.gov registry record · Phase 3
S9921, Hormone Therapy With or Without Mitoxantrone and Prednisone in Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer
A Phase 3 study of Prostate Cancer, sponsored by SWOG Cancer Research Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 983
- Enrollment target
- 20
- Study locations
NCT00004124: Completed Phase 3 study of Prostate Cancer, sponsored by SWOG Cancer Research Network.
NCT00004124 is a Phase 3 study of Prostate Cancer that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 983 participants, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (62% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00004124, a Phase 3 study of Prostate Cancer, has completed, sponsored by SWOG Cancer Research Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 983 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy plus mitoxantrone and prednisone is more effective than hormone therapy alone for prostate cancer. PURPOSE: This randomized phase III trial is studying hormone therapy, mitoxantrone, and prednisone to see how well they work compared to hormone therapy alone in treating patients who have undergone radical prostatectomy for prostate cancer.
Primary Outcome
Measured from date of randomization to date of death from any cause. Patient known to be alive are censored at date of last contact.
Conditions Studied
Interventions
- DRUG prednisone
- DRUG goserelin
- DRUG bicalutamide
- DRUG mitoxantrone hydrochloride
Study Locations (20)
California
- Alta Bates Comprehensive Cancer Center - Berkeley
- Peninsula Medical Center - Burlingame
- California Cancer Care, Incorporated - Greenbrae
- Marin Cancer Institute at Marin General Hospital - Greenbrae
- Sutter Health - Western Division Cancer Research Group - Greenbrae
- Naval Medical Center - San Diego - San Diego
- San Francisco General Hospital Medical Center - San Francisco
- UCSF Comprehensive Cancer Center - San Francisco
- California Pacific Medical Center - California Campus - San Francisco
- Veterans Affairs Medical Center - San Francisco - San Francisco
- Cancer Center of Santa Barbara - Santa Barbara
- Sansum Medical Clinic - Santa Barbara
- Santa Barbara Hematology Oncology Medical Group at Cancer Center of Santa Barbara - Santa Barbara
Arizona
- Banner Thunderbird Medical Center - Glendale
- Banner Good Samaritan Medical Center - Phoenix
- CCOP - Western Regional, Arizona - Phoenix
Alaska
- Alaska Regional Hospital Cancer Center - Anchorage
- Providence Cancer Center - Anchorage
Arkansas
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences - Little Rock
- Highlands Oncology Group - Springdale - Springdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 983 participants |
| Start Date | 1999-10-15 |
| Est. Completion | 2018-05-01 |
| Phase | Phase 3 |
What the finished NCT00004124 record still lists
NCT00004124 is an interventional study that assigns participants to a tested intervention. The registered 983 participants enrollment target is mid-sized for trials with a published cap, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (62% higher).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which prednisone is the first listed.
NCT00004124 names 20 study sites across 4 states, led by California, Arizona, Alaska.
Frequently Asked Questions
What is clinical trial NCT00004124 about?
NCT00004124 is a clinical study titled "S9921, Hormone Therapy With or Without Mitoxantrone and Prednisone in Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer". RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormo...
What is the current status of trial NCT00004124?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 983 participants. The study started on 1999-10-15. Estimated completion is 2018-05-01.
What conditions does trial NCT00004124 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT00004124?
The interventions under investigation include: prednisone (DRUG), goserelin (DRUG), bicalutamide (DRUG), mitoxantrone hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00004124?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00004124 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00004124's enrollment target sits among peer trials
983 69th of 735 higher than 667 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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