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 (DIVINE)
April 17, 2026 updated by: Mayo Clinic
MC230502 Dynamic Investigator Initiated Enterprise (DIVINE) in Prostate Cancer
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
- Other: Questionnaire Administration
- Procedure: Magnetic Resonance Imaging
- Procedure: Computed Tomography
- Procedure: Biospecimen Collection
- Procedure: Positron Emission Tomography
- Radiation: Stereotactic Body Radiation Therapy
- Procedure: Bone Scan
- Drug: Abiraterone
- Drug: Prednisone
- Drug: Darolutamide
- Drug: Apalutamide
- Drug: Degarelix
- Drug: Enzalutamide
- Drug: Goserelin
- Drug: Histrelin
- Drug: Leuprolide
- Drug: Relugolix
- Drug: Triptorelin
- Other: Patient Observation
- Radiation: Radiation Therapy
- Procedure: Image-Guided Therapy
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate and compare modified radiographic progression-free survival (mrPFS) in patients with metachronous recurrent oligometastatic prostate cancer treated with SBRT and 6 months ADT/ARPI followed by watchful wait (Group A) versus SBRT followed by watchful waiting (Group B). (De-escalation stratified by Extracellular Vesicles--Irradiation with Antiandrogen Therapy Exclusion [DEVIATE]) II. To evaluate and compare distant progression-free survival (PFS), landmarked at 12 months, in patients with biochemically recurrent prostate cancer treated with sXRT followed by watchful waiting (Group C) versus initial observation and subsequent image-guided therapy (Group D). (Biochemical Recurrence Irradiation versus Observation [BRIO])
SECONDARY OBJECTIVES:
I. To evaluate and compare overall survival (OS) between treatment groups. II. To evaluate and compare biochemical progression-free survival (bPFS) between treatment groups.
III. To evaluate and compare distant progression-free survival (PFS) starting from study registration, in patients with biochemically recurrent prostate cancer treated with sXRT followed by watchful waiting (Group C) versus initial observation and subsequent image-guided therapy (Group D).
TERTIARY OBJECTIVES:
I. To estimate rates of salvage radiotherapy to the pelvis in patients with biochemically recurrent prostate cancer treated with initial observation and subsequent image-guided therapy (Group D).
II. To evaluate the adverse event profile of the study treatments as assessed per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
III. To evaluate and compare castration-resistant prostate cancer (CRPC)-free survival between treatment groups NOTE: CRPC-free survival: radiographic progression-free survival with castrate-level testosterone (< 50ng/mL).
IV. Determine the efficacy of extracellular vesicles (EVs) as a minimal residual disease (MRD) marker.
V. Determine the efficacy of EVs as an early indicator of disease relapse. VI. Determine whether early ADT and ARPI hasten CRPC. VII. Determine how circulating tumor deoxyribonucleic acid (ctDNA) compares as a biomarker to EVs.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
DEVIATE COHORT: Patients are randomized to 1 of 2 groups.
GROUP A: 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 disease progression or unacceptable toxicity. Patients then undergo watchful waiting thereafter until disease progression.
GROUP B: Patients undergo SBRT with watchful waiting. Cycles repeat every 4 months (16 weeks) in the absence of disease progression or unacceptable toxicity.
BRIO COHORT: Patients are randomized to 1 of 2 groups.
GROUP C: Patients undergo sXRT with watchful waiting. Cycles repeat every 4 months (16 weeks) in the absence of disease progression or unacceptable toxicity.
GROUP D: 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, all patients undergo blood sample collection and positron emission tomography (PET), computed tomography (CT), magnetic resonance imaging (MRI), or bone scan throughout the trial.
Upon completion of study interventions patients are followed up every 6 months for up to 5 years.
Study Type
Interventional
Enrollment (Estimated)
532
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
Study Contact Backup
- Name: Cancer Center Clinical Trials
- Phone Number: 507-293-6386
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85054
- Recruiting
- Mayo Clinic in Arizona
-
Contact:
- Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
-
Principal Investigator:
- Jack R. Andrews, MD
-
Contact:
- Cancer Center Clinical Trials
- Phone Number: 507-293-6386
-
-
Florida
-
Jacksonville, Florida, United States, 32224-9980
- Recruiting
- Mayo Clinic in Florida
-
Contact:
- Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
-
Contact:
- Cancer Center Clinical Trials
- Phone Number: 507-293-6386
-
Principal Investigator:
- Adam M. Kase, MD
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic in Rochester
-
Contact:
- Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
-
Principal Investigator:
- Jacob J. Orme, MD, PhD
-
Contact:
- Cancer Center Clinical Trials
- Phone Number: 507-293-6386
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥ 18 years
Disease characteristics:
DEVIATE (Groups A and B only):
- Clinical confirmation of metachronous (metastatic) recurrent hormone-sensitive prostate cancer
- Five (5) or fewer metastases with at least one metastasis beyond the pelvis on advanced molecular and/or conventional imaging
- Serum testosterone > 100ng/dL
BRIO (Gropus C & D only):
- Prostate-specific antigen (PSA) between 0.2 and 1.5 ng/mL with PSA above 0.2 on at least two consecutive measurements at least 5 days apart
- No local or metastatic recurrence apparent on advanced molecular imaging
- Serum testosterone > 100 ng/dL
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2
- Hemoglobin ≥ 8.0 g/dL (obtained ≤ 15 days prior to registration)
- Absolute neutrophil count (ANC) ≥ 1500/mm^3 (obtained ≤ 15 days prior to registration)
- Platelet count ≥ 80,000/mm^3 (obtained ≤ 15 days prior to registration)
- Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x upper limit of normal (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)
- Provide written informed consent
- Ability to complete questionnaire(s) by themselves or with assistance
- Willingness to provide mandatory blood specimens for correlative research
- Willingness to provide tissue specimens for correlative research
- Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
Exclusion Criteria:
Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown
- Pregnant persons
- Nursing persons
- Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception
- Prior metastasis-directed therapy
Any of the following prior therapies:
- Surgery ≤ 3 weeks prior to registration
- Chemotherapy for prostate cancer at any time
- Androgen receptor pathway inhibitor such as abiraterone, apalutamide, darolutamide, or enzalutamide in the last 2 years
Uncontrolled intercurrent non-cardiac illness including, but not limited to:
- Ongoing or active infection
- Psychiatric illness/social situations
- Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy
- Any other conditions that would limit compliance with study requirements
- Receiving any other investigational agent which would be considered as a treatment for prostate cancer.
- Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment EXCEPTION: Grade 1 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Or psychiatric illness/social situations that would limit compliance with study requirements
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Other active malignancy ≤ 3 years prior to registration
- EXCEPTIONS: Curatively treated non-melanotic skin cancer or papillary thyroid cancer
- NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment such as chemotherapy or antihormonal therapy for their cancer
- History of myocardial infarction ≤ 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
Ancillary studies
Undergo MRI
Other Names:
Undergo CT
Other Names:
Undergo blood sample collection
Other Names:
Undergo PET
Other Names:
Undergo SBRT
Other Names:
Undergo bone scan
Other Names:
Given abiraterone
Other Names:
Given prednisone
Other Names:
Given darolutamide
Other Names:
Given apalutamide
Other Names:
Given degarelix
Other Names:
Given enzalutamide
Other Names:
Given goserelin
Other Names:
Given histrelin
Given leuprolide
Other Names:
Given relugolix
Other Names:
Given triptorelin
Other Names:
Undergo watchful waiting or initial observation
Other Names:
|
|
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.
|
Ancillary studies
Undergo MRI
Other Names:
Undergo CT
Other Names:
Undergo blood sample collection
Other Names:
Undergo PET
Other Names:
Undergo SBRT
Other Names:
Undergo bone scan
Other Names:
Undergo watchful waiting or initial observation
Other Names:
Undergo sXRT
Other Names:
|
|
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.
|
Ancillary studies
Undergo MRI
Other Names:
Undergo CT
Other Names:
Undergo blood sample collection
Other Names:
Undergo PET
Other Names:
Undergo bone scan
Other Names:
Undergo watchful waiting or initial observation
Other Names:
|
|
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.
|
Ancillary studies
Undergo MRI
Other Names:
Undergo CT
Other Names:
Undergo blood sample collection
Other Names:
Undergo PET
Other Names:
Undergo bone scan
Other Names:
Undergo watchful waiting or initial observation
Other Names:
Undergo image-guided therapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified radiographic progression-free survival (mrPFS) (Groups A & B)
Time Frame: Up to 5 years
|
Modified radiographic progression-free survival (mrPFS) is defined as the time from the date of randomization (enrollment to study) to the date of the first occurrence of the following events: death due to all causes or radiographic progression per Prostate Cancer Working Group 3 Criteria, which is not addressable by stereotactic body radiation therapy (SBRT).
Radiographic progression not addressable by SBRT per the treating physician NOTE: Radiographic progression disease that can be addressed by SBRT will not be an mrPFS event.
NOTE: Event-free patients will be censored at their last imaging assessment.
|
Up to 5 years
|
|
Distant progression-free survival (PFS) (Groups C & D)
Time Frame: Up to 5 years
|
Defined as the date from the date of randomization + 1 year to the date of the first occurrence of death due to all causes or distant progression.
Local progression will NOT be considered a distant progression event.
Event-free patients will be censored at their last imaging assessment or prostate-specific antigen evaluation, whichever is later.
|
Up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival (OS)
Time Frame: Up to 5 years
|
Defined as time from randomization (enrolled to study) to the date of death due to any cause.
Will be conducted on modified intent-to-treat (mITT) and per-protocol (PP) populations whenever it is applicable and plausible.
Safety-related analyses will be performed on the safety population.
|
Up to 5 years
|
|
Biochemcial progression-free survival (bPFS)
Time Frame: Up to 5 years
|
Defined as the time from randomization (enrollment to study) up to the date of death due to any cause or biochemical progressive disease, whichever occurs first.
Will be conducted on mITT and PP populations whenever it is applicable and plausible.
Safety-related analyses will be performed on the safety population.
|
Up to 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jacob J. Orme, MD, PhD, Mayo Clinic in Rochester
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 3, 2024
Primary Completion (Estimated)
February 28, 2031
Study Completion (Estimated)
February 28, 2031
Study Registration Dates
First Submitted
April 16, 2024
First Submitted That Met QC Criteria
April 16, 2024
First Posted (Actual)
April 23, 2024
Study Record Updates
Last Update Posted (Actual)
April 20, 2026
Last Update Submitted That Met QC Criteria
April 17, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Prostatic Neoplasms
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Health Services Administration
- Pituitary Hormone-Releasing Hormones
- Hypothalamic Hormones
- Peptide Hormones
- Neuropeptides
- Peptides
- Amino Acids, Peptides, and Proteins
- Oligopeptides
- Nerve Tissue Proteins
- Proteins
- Investigative Techniques
- Methods
- Therapeutics
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Surgical Procedures, Operative
- Quality of Health Care
- Physical Phenomena
- Polycyclic Compounds
- Pregnadienes
- Pregnanes
- Steroids
- Fused-Ring Compounds
- Chemistry Techniques, Analytical
- Spectrum Analysis
- Pregnadienediols
- Electromagnetic Phenomena
- Magnetic Phenomena
- Androstenes
- Androstanes
- Stereotaxic Techniques
- Neurosurgical Procedures
- Outcome Assessment, Health Care
- Outcome and Process Assessment, Health Care
- Electromagnetic Radiation
- Radiation, Ionizing
- Gonadotropin-Releasing Hormone
- Abiraterone Acetate
- Prednisone
- Leuprolide
- Goserelin
- Triptorelin Pamoate
- acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide
- relugolix
- darolutamide
- Radiotherapy
- Observation
- Radiation
- abiraterone
- Specimen Handling
- Magnetic Resonance Spectroscopy
- Radiosurgery
- Watchful Waiting
- enzalutamide
- X-Rays
- deltacortene
- prednylidene
- Radiotherapy, Image-Guided
- apalutamide
- histrelin
Other Study ID Numbers
- MC230502 (Mayo Clinic in Rochester)
- 23-012176 (Other Identifier: Mayo Clinic Institutional Review Board)
- R01CA286127 (U.S. NIH Grant/Contract)
- R01CA300454 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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