RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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)

Quick Facts

Study Start:2021-07-01
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04787744

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * 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).
  2. * Prior malignancy, except the following:
  3. * Adequately treated non-melanomatous skin cancer;
  4. * Adequately treated Stage 0, I, or II cancer from which the patient is currently in complete remission; or
  5. * Any other cancer from which the patient has been disease free for three years.
  6. * Presence of a symptomatic metastasis that requires palliative radiotherapy.
  7. * Any known brain metastases, presence of leptomeningeal disease, malignant spinal cord compression, or malignant cauda equina syndrome.
  8. * 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).
  9. * 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).
  10. * Any other previous or current condition, which, in the judgement of the LSI, is likely to interfere with any STARPORT treatments or assessments.

Contacts and Locations

Study Contact

Abhishek Solanki, MD MS
CONTACT
(708) 202-8387
Abhishek.Solanki@va.gov

Principal Investigator

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

Study Locations (Sites)

VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, 90822
United States
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073
United States
Bay Pines VA Healthcare System, Pay Pines, FL
Bay Pines, Florida, 33744
United States
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030
United States
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884
United States
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
United States
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
United States
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
United States
Kansas City VA Medical Center, Kansas City, MO
Kansas City, Missouri, 64128
United States
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
East Orange, New Jersey, 07018
United States
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010-5011
United States
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705
United States
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106
United States
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104-4551
United States
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
United States
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, 23249
United States
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705-2254
United States
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin, 53295-1000
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

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

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 Registration Dates

Study Start Date2021-07-01
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2021-07-01
Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

  • Prostate Cancer
  • Metastasis
  • Oligorecurrence
  • PET-directed local therapy
  • Standard Systemic Therapy
  • SBRT
  • Oligometastasis
  • Oligorecurrent
  • Metastasis-directed therapy
  • Salvage Local Therapy
  • Recurrent Prostate Cancer
  • Fluciclovine
  • PSMA
  • Choline

Additional Relevant MeSH Terms

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