RecruitingPhase 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

MC230502 Dynamic Investigator Initiated Enterprise (DIVINE) in Prostate Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months, 5 years
  • Procedures mentioned: Blood draws, MRI scans, CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Cycles repeat every 4 months (16 weeks) for up to 6 months 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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests focused radiation with hormone-blocking drugs started right away or later for prostate cancer that has returned and spread but still responds to hormones. It also tests radiation after earlier treatment, including whether radiation to the pelvis helps keep cancer from spreading. The study is for adults who meet the rules for one of these study groups.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Groups A and B: Have prostate cancer that has returned, spread, and still responds to hormones. Scans must show 5 or fewer areas of spread, with at least one outside the pelvis.
  • Groups C and D: Have a PSA blood test level of 0.15–1.5 ng/mL, with at least two results of 0.15 or higher at least 5 days apart. Special scans must show no cancer return or spread.
  • Have testosterone above 100 ng/dL, or a doctor must judge that it is not at a very low level.
  • Be able to care for yourself and be out of bed or a chair for at least half of waking hours.
  • Blood tests within 15 days before signing up must meet study rules for blood cell counts, liver health, and kidney function.
  • Give written consent and be able to complete surveys, alone or with help.
  • Agree to give blood samples, allow access to tissue samples for research, and return to the study center for follow-up during active monitoring.

Who can't join

  • Are pregnant or nursing, or could become pregnant or father a child but will not use adequate birth control.
  • Have had treatment aimed at areas where the cancer has spread.
  • Had surgery within 3 weeks, chemotherapy for prostate cancer at any time, or certain hormone-blocking drugs within 2 years, such as abiraterone, apalutamide, darolutamide, or enzalutamide.
  • Have an uncontrolled illness or serious condition that could make treatment unsafe or prevent following study rules. Examples include infection, heart problems, mental health or social problems, or breathing trouble at rest that needs constant oxygen.
  • Are receiving another experimental drug to treat the prostate cancer.
  • Have not recovered from short-term, reversible effects of past treatment. Mild nerve problems affecting feeling are allowed if stable for at least 3 months after treatment ended.
  • Had another active cancer within 3 years, except non-melanoma skin cancer or papillary thyroid cancer treated to cure it. People with a past cancer must not still receive cancer-specific treatment for it.
  • Had a heart attack within 6 months, or have heart failure requiring ongoing treatment for life-threatening heart rhythms.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 or clinically deemed non-castrate * BRIO (Groups C \& D only): * Prostate-specific antigen (PSA) between 0.15 and 1.5 ng/mL with PSA ≥ 0.15 ng/mL on at least two measurements at least 5 days apart * No local or metastatic recurrence apparent on advanced molecular imaging * Serum testosterone \> 100 ng/dL or clinically deemed non-castrate * 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) or 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 allow access 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 inhibitors 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 sites (3)

AZ

FL

MN