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NCT00853697 · ClinicalTrials.gov registry record · Phase 2
Exogenous Testosterone Plus Dutasteride for the Treatment of Castrate Metastatic Prostate Cancer
A Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT00853697: Completed Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT00853697 is a Phase 2 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00853697, a Phase 2 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
Usually, the male hormone testosterone makes prostate cancer cells grow. Lowering testosterone usually stops the growth of prostate cancer. However, after a period of time without testosterone, prostate cancer cells learn to grow again. You are able to join this trial because your prostate cancer is growing even though you have very low levels of testosterone. Studies have shown that high doses of testosterone, in this situation, can cause prostate cancer cells to stop growing. The investigators did a study several years ago in which the investigators gave high doses of testosterone to patients such as yourself. The investigators showed that giving testosterone in this situation was safe. The investigators also showed that the investigators could, in some cases, make the PSA go down using high-dose testosterone. The investigators believe that they can improve this type of treatment by combining testosterone with another drug called dutasteride. Dutasteride is another type of hormone. It should make testosterone levels rise. The investigators believe that combination of dutasteride and testosterone will be more a more powerful regimen against your cancer than testosterone alone.
Interventions
- OTHER testosterone (AndroGel®) with the 5α-reductase inhibitor dutasteride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2009-03 |
| Est. Completion | 2012-11 |
| Phase | Phase 2 |
What the finished NCT00853697 record still lists
NCT00853697 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which testosterone (AndroGel®) with the 5α-reductase inhibitor dutasteride is the first listed.
NCT00853697 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00853697 about?
NCT00853697 is a clinical study titled "Exogenous Testosterone Plus Dutasteride for the Treatment of Castrate Metastatic Prostate Cancer". Usually, the male hormone testosterone makes prostate cancer cells grow. Lowering testosterone usually stops the growth of prostate cancer. However, after a period of time without testosterone, prostate cancer cells learn to grow again. You are able to join this trial because your prostate cancer i...
What is the current status of trial NCT00853697?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2009-03. Estimated completion is 2012-11.
What interventions are being tested in trial NCT00853697?
The interventions under investigation include: testosterone (AndroGel®) with the 5α-reductase inhibitor dutasteride (OTHER).
Who is sponsoring clinical trial NCT00853697?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00853697's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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