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

Description

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.

Conditions

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

Study Overview

Study Details

Study overview

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.

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)

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

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Long Beach

VA Long Beach Healthcare System, Long Beach, CA, Long Beach, California, United States, 90822

West Los Angeles

VA Greater Los Angeles Healthcare System, West Los Angeles, CA, West Los Angeles, California, United States, 90073

Bay Pines

Bay Pines VA Healthcare System, Pay Pines, FL, Bay Pines, Florida, United States, 33744

Hines

Edward Hines Jr. VA Hospital, Hines, IL, Hines, Illinois, United States, 60141-3030

Indianapolis

Richard L. Roudebush VA Medical Center, Indianapolis, IN, Indianapolis, Indiana, United States, 46202-2884

Baltimore

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD, Baltimore, Maryland, United States, 21201

Boston

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA, Boston, Massachusetts, United States, 02130

Ann Arbor

VA Ann Arbor Healthcare System, Ann Arbor, MI, Ann Arbor, Michigan, United States, 48105

Minneapolis

Minneapolis VA Health Care System, Minneapolis, MN, Minneapolis, Minnesota, United States, 55417-2309

Kansas City

Kansas City VA Medical Center, Kansas City, MO, Kansas City, Missouri, United States, 64128

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Any current or prior evidence of castration-resistant prostate cancer, defined as two consecutive rises in serum PSA, obtained at a minimum of 1-week interval, with the final PSA value \>/= 1 ng/ml, while having a total testosterone \< 50 ng/dl).
  • * Prior malignancy, except the following:
  • * Adequately treated non-melanomatous skin cancer;
  • * Adequately treated Stage 0, I, or II cancer from which the patient is currently in complete remission; or
  • * Any other cancer from which the patient has been disease free for three years.
  • * Presence of a symptomatic metastasis that requires palliative radiotherapy.
  • * Any known brain metastases, presence of leptomeningeal disease, malignant spinal cord compression, or malignant cauda equina syndrome.
  • * Prior nodal, bone, or visceral metastasis after curative-intent therapy other than those identified on the enrollment imaging studies which make the patient ineligible for PET-directed local therapy (per investigator discretion).
  • * Prior radiation therapy to any sites requiring PET-directed local therapy or salvage local therapy that will lead to prohibitively high risk of toxicity from subsequent local therapy, as determined by the treating radiation oncologist (if radiation is intended as the study local therapy) or surgeon/urologist (if surgery is intended as the study local therapy).
  • * Any other previous or current condition, which, in the judgement of the LSI, is likely to interfere with any STARPORT treatments or assessments.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

VA Office of Research and Development,

Abhishek Solanki, MD MS, PRINCIPAL_INVESTIGATOR, Edward Hines Jr. VA Hospital, Hines, IL

Study Record Dates

2025-12-01