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

Conditions

• Biochemically Recurrent Prostate Carcinoma
• Castration-resistant Prostate Cancer
• Recurrent Castration-Sensitive Prostate Carcinoma
• Recurrent Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Abiraterone — DRUG
  Given abiraterone
• Apalutamide — DRUG
  Given apalutamide
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Bone Scan — PROCEDURE
  Undergo bone scan
• Computed Tomography — PROCEDURE
  Undergo CT
• Darolutamide — DRUG
  Given darolutamide
• Degarelix — DRUG
  Given degarelix
• Enzalutamide — DRUG
  Given enzalutamide
• Goserelin — DRUG
  Given goserelin
• Histrelin — DRUG
  Given histrelin
• Leuprolide — DRUG
  Given leuprolide
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Patient Observation — OTHER
  Undergo watchful waiting or initial observation
• Positron Emission Tomography — PROCEDURE
  Undergo PET
• Prednisone — DRUG
  Given prednisone
• Questionnaire Administration — OTHER
  Ancillary studies
• Relugolix — DRUG
  Given relugolix
• Stereotactic Body Radiation Therapy — RADIATION
  Undergo SBRT
• Triptorelin — DRUG
  Given triptorelin
• Radiation Therapy — RADIATION
  Undergo sXRT
• Image-Guided Therapy — PROCEDURE
  Undergo image-guided therapy

Study Details

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.

Key Dates

Start date

Jun 3, 2024

Status verified

Apr 2026

Primary completion

Feb 28, 2031

Completion

Feb 28, 2031

Study Design

Enrollment

532 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Group A (SBRT, APRI, ADT)
  Patients undergo SBRT and receive ARPI (abiraterone and prednisone, apalutamide, darolutamide, or enzalutamide) and ADT (leuprolide, triptorelin, histrelin, goserelin, degarelix, or relugolix). Cycles repeat every 4 months (16 weeks) for up to 6 months in the absence of unacceptable toxicity. Patients then undergo watchful waiting thereafter until disease progression. Additionally, patients undergo blood sample collection and PET, CT, MRI, or bone scan throughout the trial.
• Experimental: Group B (SBRT, watchful waiting)
  Patients undergo SBRT with watchful waiting. Cycles repeat every 4 months (16 weeks) in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and PET, CT, MRI, or bone scan throughout the trial.
• Experimental: Group C (sXRT, watchful waiting)
  Patients undergo sXRT with watchful waiting. Cycles repeat every 4 months (16 weeks) in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and PET, CT, MRI, or bone scan throughout the trial.
• Active Comparator: Group D (initial observation, image-guided therapy)
  Patients undergo initial observation with subsequent image-guided therapy based on visualized distant progression, which may consist of cross-over to groups A \& B, other off-trial radiotherapy, systemic therapy, surgical intervention, or other intervention per clinician discretion. Cycles repeat every 4 months (16 weeks) in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and PET, CT, MRI, or bone scan throughout the trial.

Primary Outcome Measure

Modified radiographic progression-free survival (mrPFS) (Groups A & B) [ Time Frame: Up to 5 years ]

Central Contacts

• Clinical Trials Referral Office
  855-776-0015
  [email protected]
• Cancer Center Clinical Trials
  507-293-6386

Locations (3)

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