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NCT06378866 · ClinicalTrials.gov registry record · Phase 2
Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial
A Phase 2 study of Recurrent Prostate Cancer and Castration-resistant Prostate Cancer, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 532
- Enrollment target
- 3
- Study locations
NCT06378866 is a Phase 2 study of Recurrent Prostate Cancer and Castration-resistant Prostate Cancer that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 532 participants, above the 113-participant average among 21 other Recurrent Prostate Cancer trials with a reported enrollment target (371% higher). The trial reports 3 study locations across 3 states.
The verdict
NCT06378866, a Phase 2 study of Recurrent Prostate Cancer and Castration-resistant Prostate Cancer, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 532 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase II trial studies the effects of stereotactic body radiation therapy (SBRT) and the timing of treatment with androgen receptor pathway inhibitor (ARPI) plus androgen deprivation therapy (ADT) in treating patients with hormone sensitive prostate cancer that has spread from where it first started to other places in the body (metastatic), and that has come back after a period of improvement (recurrent). It also studies the effects of salvage radiation therapy (sXRT) on prostate cancer and to see if radiation to the pelvis helps prevent prostate cancer from spreading elsewhere. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Androgen can cause the growth of prostate cells. ADT lowers the amount of androgen made by the body. This may help stop the growth of tumor cells that need androgen to grow. Androgen receptor pathway inhibitors work by blocking the effects of androgen to stop the growth and spread of tumor cells. sXRT is a targeted radiation treatment for the prostate, typically given when cancer possibly returns after surgery or radiation. Its goal is to destroy any tumor cells in the area. Giving SBRT alone with watchful waiting may be as effective in treating prostate cancer as giving SBRT together with ARPI and ADT and sXRT may be effective in treating prostate cancer and preventing it from spreading elsewhere.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Bone Scan
- DRUG Apalutamide
- DRUG Abiraterone
Study Locations (3)
Arizona
- Mayo Clinic in Arizona - Phoenix
Florida
- Mayo Clinic in Florida - Jacksonville
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 532 participants |
| Start Date | 2024-06-03 |
| Est. Completion | 2029-05-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06378866
The ClinicalTrials.gov registry entry for NCT06378866 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 532 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 113-participant average among 21 other Recurrent Prostate Cancer trials with a reported enrollment target (371% higher). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Recurrent Prostate Cancer appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06378866 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Arizona, Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT06378866 about?
NCT06378866 is a clinical study titled "Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial". This phase II trial studies the effects of stereotactic body radiation therapy (SBRT) and the timing of treatment with androgen receptor pathway inhibitor (ARPI) plus androgen deprivation therapy (ADT) in treating patients with hormone sensitive prostate cancer that has spread from where it first st...
What is the current status of trial NCT06378866?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 532 participants. The study started on 2024-06-03. Estimated completion is 2029-05-31.
What conditions does trial NCT06378866 study?
This clinical trial studies the following conditions: Recurrent Prostate Cancer, Castration-resistant Prostate Cancer, Biochemically Recurrent Prostate Carcinoma, Recurrent Castration-Sensitive Prostate Carcinoma.
What interventions are being tested in trial NCT06378866?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Bone Scan (PROCEDURE), Apalutamide (DRUG), Abiraterone (DRUG).
Who is sponsoring clinical trial NCT06378866?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06378866 being conducted?
This trial has 3 study locations across Arizona, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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