MC230502 Dynamic Investigator Initiated Enterprise (DIVINE) in Prostate Cancer
Mayo Clinic
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.
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 w…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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 o…
Interventions
- DrugAbiraterone
Given abiraterone
- DrugApalutamide
Given apalutamide
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureBone Scan
Undergo bone scan
- ProcedureComputed Tomography
Undergo CT
- DrugDarolutamide
Given darolutamide
- DrugDegarelix
Given degarelix
Locations (3)
- Mayo Clinic in ArizonaPhoenix, Arizona
- Mayo Clinic in FloridaJacksonville, Florida
- Mayo Clinic in RochesterRochester, Minnesota