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NCT03056638 · ClinicalTrials.gov registry record · Phase 3
Trial of ADT and SBRT Versus SBRT for Intermediate Prostate Cancer
A Phase 3 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Terminated
- Registry status
- Phase 3
- Development phase
- 56
- Enrollment target
NCT03056638: Clinical Trial Phase 3 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT03056638 is a Phase 3 study that was terminated before completion, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 56 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03056638, a Phase 3 study, was terminated before completion, sponsored by Memorial Sloan Kettering Cancer Center.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 56 participants
- Enrollment target
Study Summary
Stereotactic body radiation therapy (SBRT) is a very precise form of radiation therapy that allows the physician to deliver more radiation dose in a single session. Because of this, the number of radiation sessions can be reduced from the typical 45-48 sessions, as in conventional daily session radiation, to 5 sessions given every other day over a week and a half. Giving the radiation at a higher dose during each treatment may be more effective in killing the prostate cancer cells than the standard way of using external radiation therapy where a small amount of radiation is given over many sessions. Androgen Deprivation Therapy (ADT) or hormonal therapy is one of the methods to treat intermediate risk prostate cancer. This therapy works by reducing the level of testosterone and stopping them from affecting your cancer. The ADT used in this study is known as Degarelix. Degarelix is an approved medication that reduces the body's production of testosterone; this medication is usually given to all men with intermediate risk prostate cancer getting external radiation. This study is a randomized study to find out whether combining stereotactic (also known as precision) radiation to the prostate cancer combined with a short course of Degarelix will result in a greater likelihood of killing the cancer in the prostate compared to stereotactic radiation therapy given alone. It has been shown that the combination of radiation with medications that interfere with testosterone production and its effects makes prostate cancer cells more sensitive to the radiation.
Primary Outcome
compare 2-year biopsy positivity rate of intermediate risk prostate cancer patients treated with SBRT + short course ADT versus SBRT alone.
Interventions
- DRUG Degarelix
- RADIATION stereotactic body radiosurgery (SBRT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2017-03-28 |
| Est. Completion | 2023-08-16 |
| Phase | Phase 3 |
Why NCT03056638 stopped before completion
NCT03056638 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Degarelix is the first listed.
NCT03056638 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03056638 about?
NCT03056638 is a clinical study titled "Trial of ADT and SBRT Versus SBRT for Intermediate Prostate Cancer". Stereotactic body radiation therapy (SBRT) is a very precise form of radiation therapy that allows the physician to deliver more radiation dose in a single session. Because of this, the number of radiation sessions can be reduced from the typical 45-48 sessions, as in conventional daily session radi...
What is the current status of trial NCT03056638?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 56 participants. The study started on 2017-03-28. Estimated completion is 2023-08-16.
What interventions are being tested in trial NCT03056638?
The interventions under investigation include: Degarelix (DRUG), stereotactic body radiosurgery (SBRT) (RADIATION).
Who is sponsoring clinical trial NCT03056638?
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 NCT03056638's enrollment target sits among peer trials
56 1827th of 2000 higher than 167 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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