OncoMatch/Clinical Trials/NCT06378866
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
Is NCT06378866 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for recurrent castration-sensitive prostate carcinoma.
Treatment: Abiraterone · Apalutamide · Darolutamide · Degarelix · Enzalutamide · Goserelin · Histrelin · Leuprolide · Prednisone · Relugolix · Triptorelin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: metastasis-directed therapy
Prior metastasis-directed therapy
Cannot have received: chemotherapy
Chemotherapy for prostate cancer at any time
Cannot have received: androgen receptor pathway inhibitor (abiraterone, apalutamide, darolutamide, enzalutamide)
Exception: in the last 2 years
Androgen receptor pathway inhibitor such as abiraterone, apalutamide, darolutamide, or enzalutamide in the last 2 years
Cannot have received: surgery
Exception: ≤ 3 weeks prior to registration
Surgery ≤ 3 weeks prior to registration
Lab requirements
Blood counts
Hemoglobin ≥ 8.0 g/dL; ANC ≥ 1500/mm^3; Platelet count ≥ 80,000/mm^3
Kidney function
Calculated creatinine clearance ≥ 30 ml/min using the Cockcroft-Gault formula
Liver function
ALT and AST ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement)
Hemoglobin ≥ 8.0 g/dL (obtained ≤ 15 days prior to registration); ANC ≥ 1500/mm^3 (obtained ≤ 15 days prior to registration); Platelet count ≥ 80,000/mm^3 (obtained ≤ 15 days prior to registration); ALT and AST ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration); Calculated creatinine clearance ≥ 30 ml/min using the Cockcroft-Gault formula (obtained ≤ 15 days prior to registration)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Arizona · Phoenix, Arizona
- Mayo Clinic in Florida · Jacksonville, Florida
- Mayo Clinic in Rochester · Rochester, Minnesota
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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