RecruitingPhase 2Phase 3NCT04787744

Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer

Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for OligoRecurrenT Prostate Cancer (VA STARPORT)

Sponsor

VA Office of Research and Development

Enrollment

464 participants

Start Date

Jul 1, 2021

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer Metastatic Prostate Cancer Oligometastasis Recurrent Prostate Cancer Oligorecurrence De Novo Prostate Cancer

Summary

This is a prospective, open-label, multi-center seamless phase II to phase III randomized clinical trial designed to compare SST with or without PET-directed local therapy in improving the castration-resistant prostate cancer-free survival (CRPC-free survival) for Veterans with oligometastatic prostate cancer. Oligometastasis will be defined as 1-10 sites of metastatic disease based on the clinical determination of the LSI which incorporates all imaging, clinical, and pathologic data available.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Veterans Affairs trial is for men with prostate cancer that has spread to a small number of sites in the body (called oligometastatic prostate cancer). The study compares standard drug therapy alone versus standard drug therapy plus targeted radiation to the metastatic sites, to see if treating those specific spots improves outcomes. **You may be eligible if...** - You are 18 or older and a Veteran - You have a confirmed prostate cancer diagnosis - Your cancer has spread to only a few sites (oligometastatic disease) confirmed on imaging - You previously received curative treatment (surgery or radiation) for prostate cancer - You are in good enough health to participate (ECOG performance status ≤2) **You may NOT be eligible if...** - Your cancer has spread to many sites throughout the body - You have not previously received curative-intent treatment for prostate cancer - You are in very poor health Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREPET-directed Local Therapy using Surgery

Surgery will be used to treat metastases.

RADIATIONPET-directed Local Therapy using Radiation

Radiation therapy will be used to treat metastases. Radiation options include: 1. Stereotactic body radiotherapy (SBRT) using 1-10 fractions 2. Conventionally fractionated radiotherapy using elective nodal radiotherapy and a simultaneous integrated boost to involved nodes The selection of the form of metastasis-directed radiotherapy for each metastasis will be determined using shared decision-making between the treating physician and the Veteran.

OTHERSalvage Local Therapy for locally recurrent disease

For Veterans who have a local recurrence in addition to oligorecurrent metastatic lesions, they will undergo salvage local therapy using brachytherapy, SBRT, surgery, cryotherapy or HIFU. The selection of modality of salvage local therapy will be determined using shared decision-making between the treating physician and Veteran.

DRUGGoserelin, Histrelin, Leuprolide & Triptorelin

Androgen deprivation therapy (ADT) using an LHRH agonist

DRUGADT + Nilutamide, Flutamide, & Bicalutamide

ADT adding anti-androgen therapy to an LHRH agonist

DRUGDegarelix & Relugolix

ADT using an LHRH Antagonist.

DRUGADT + Docetaxel +/- prednisone

Enhanced SST using chemohormonal therapy

DRUGADT + Abiraterone + Prednisone

Enhanced SST using Abiraterone + Prednisone

DRUGADT + Abiraterone + Methylprednisolone

Enhanced SST using Abiraterone + Methylprednisolone

DRUGADT + Apalutamide

Enhanced SST using ADT + Apalutamide

DRUGADT + Enzalutamide

Enhanced SST using ADT + Enzalutamide

RADIATIONProstate-directed Radiation for De novo oligometastatic prostate cancer

Veterans in ARM 1 will receive prostate-directed RT only and NO treatment to any nodal or distant metastatic sites. Acceptable dose/fractionations include 55 Gy in 20 fractions and 36 Gy in 6 fractions. Veterans in ARM 2 should receive prostate-directed local therapy using radiotherapy or radical prostatectomy in addition to PET-directed local therapy to metastases.

Locations(20)

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, United States

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, United States

Washington DC VA Medical Center, Washington, DC

Washington D.C., District of Columbia, United States

Bay Pines VA Healthcare System, Pay Pines, FL

Bay Pines, Florida, United States

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, United States

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, United States

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, United States

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, United States

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, United States

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, United States

Kansas City VA Medical Center, Kansas City, MO

Kansas City, Missouri, United States

East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

East Orange, New Jersey, United States

VA NY Harbor Healthcare System, New York, NY

New York, New York, United States

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, United States

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, United States

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, United States

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, United States

Clement J. Zablocki VA Medical Center, Milwaukee, WI

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04787744

Related Trials

Photodynamic Therapy of Primary Localized Prostate Cancer With the SpectraCure P18 System

NCT068073593 locations

Multiparametric Magnetic Resonance Imaging of the Prostate to Assess Disease Progression and Genomics in Patients Undergoing Active Surveillance for Prostate Cancer

NCT046926751 location

A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer

NCT0700515433 locations

DESTINY-PANTUMOUR04

NCT0712400017 locations

A Trial to Learn How Safe AZD9750 is and How Well it Works in People With Metastatic Prostate Cancer When Given With or Without Other Anticancer Drugs

NCT0733644618 locations