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NCT00283803 · ClinicalTrials.gov registry record · Phase 2
Exisulind and Intermittent Androgen Suppression (ADT) in Biochemical Relapsed Prostate Cancer
A Phase 2 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
NCT00283803 is a Phase 2 study that has completed, run by University of Washington. The registered enrollment target is 32 participants.
The verdict
NCT00283803, a Phase 2 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
Study Summary
The purpose of this research study is to determine if an investigational drug called Exisulind will extend the "off-treatment" period of patients receiving Intermittent Androgen Suppression (ADT). There is evidence suggesting that alternating between periods of treatment and no treatment with androgen suppressants may delay the time to develop androgen-insensitive progression and improve overall quality of life. During intermittent androgen suppression (IAS) treatments, men receive a luteinizing hormone-releasing hormone (LHRH) agonist and antiandrogen for a fixed period of time (approximately 9 months) and then enter an off-treatment period, whose length will vary, depending on the rate of rise in the patient's Prostate-Specific Antigen (PSA). Once the PSA reaches an established threshold (1 ng/mL in men who have had a prostatectomy or 4 ng/ml in men with an intact prostate), androgen suppression will be re-initiated for another 9 months. These cycles of on-treatment/off-treatment will be repeated until patient no longer responds to the androgen suppression and it is clear that their cancer is progressing. It has been observed that off-treatment periods tend to become shorter with each successive cycle of androgen suppression, presumably due to the emergence of androgen-independent clones. This study proposes to look at exisulind, a pro-apoptotic drug, which may extend the off-treatment period in patients receiving IAS.
Interventions
- DRUG Exisulind
- DRUG Antiandrogen
- DRUG luteinizing hormone-releasing hormone (LHRH) agonist
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2002-03-12 |
| Est. Completion | 2011-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00283803
The ClinicalTrials.gov registry entry for NCT00283803 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Exisulind is the first listed.
NCT00283803 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00283803 about?
NCT00283803 is a clinical study titled "Exisulind and Intermittent Androgen Suppression (ADT) in Biochemical Relapsed Prostate Cancer". The purpose of this research study is to determine if an investigational drug called Exisulind will extend the "off-treatment" period of patients receiving Intermittent Androgen Suppression (ADT). There is evidence suggesting that alternating between periods of treatment and no treatment with andro...
What is the current status of trial NCT00283803?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2002-03-12. Estimated completion is 2011-10.
What interventions are being tested in trial NCT00283803?
The interventions under investigation include: Exisulind (DRUG), Antiandrogen (DRUG), luteinizing hormone-releasing hormone (LHRH) agonist (DRUG).
Who is sponsoring clinical trial NCT00283803?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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