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)

Who is this study for? Patients with Prostate Cancer
What treatments are being studied? Goserelin, Histrelin, Leuprolide, Triptorelin+Androgen Deprivation Therapy+Nilutamide, Flutamide, Bicalutamide+Degarelix+Androgen Deprivation Therapy+Docetaxel +/- Prednisone+Androgen Deprivation Therapy+Abiraterone+Prednisone+Androgen Deprivation Therapy+Abiraterone+Methylprednisolone+Androgen Deprivation Therapy+Apalutamide+Androgen Deprivation Therapy+Enzalutamide
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug, Procedure, Radiation, Other
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Age 18 years. Ability to provide Informed Consent for participation in the study ECOG Performance Status 2 at time of enrollment. Prostate cancer, confirmed histologically or cytologically. If original documentation of histology and cytology are not available, documentation of prostate cancer satisfies these criteria. If recurrent, prior curative-intent local therapy to all sites of prostate cancer with either upfront radiotherapy or prostatectomy with or without post-operative radiotherapy.

⁃ If recurrent, PSA suspicious for biochemical recurrence after local therapy, with lab value(s) taken prior to start of SST (if current SST has already started) or within 90 days prior to enrollment if not already on SST, and meeting one of the three below categories:

⁃ PSA 0.2 ng/ml x 2 after prostatectomy +/- post-operative radiotherapy; Elevation of PSA 2 ng/ml above the nadir after definitive radiotherapy; Or Two consecutively elevated PSAs with evidence of metastasis on the imaging Studies.

• Serum testosterone obtained prior to randomization based on one of the criteria below:

⁃ For patients who have a history of a prior episode of therapy with SST agents for prostate cancer, a total testosterone 100 ng/dl after completion of the prior episode of SST and before the start of current SST or within 30 days of starting current SST if the patient has already started SST for recurrence.

⁃ For patients who have no prior history of an episode of therapy with SST agents and have already started SST for recurrence, this pre-SST testosterone is not required.

⁃ CT or MRI abdomen/pelvis performed prior to start of SST (if current SST has already started) or within 90 days prior to enrollment if not already on SST. The results from the CT component of the PET/CT can be used to fulfill this criterion. This is optional for patients who have a PSMA PET/CT. Yechnetium (Tc99m-MDP) or sodium fluoride (NaF) bone scan (sodium fluoride preferred) performed prior to start of SST (if current SST has already started), or within 90 days prior to enrollment if not already on SST. This is optional for patients who have a PSMA PET/CT. Prostate PET/CT (currently PSMA, Fluciclovine, choline) performed prior to start of SST (if current SST has already started), or within 90 days prior to enrollment if not already on SST.

⁃ 1-10 lesions suspicious for nodal recurrence or metastasis from prostate cancer as determined by the investigator based on the above imaging studies.

⁃ Has already undergone NPOP sequencing or a plan is in place for NPOP sequencing for prostate cancer.

⁃ For participants on SST at the time of enrollment only:

⁃ Has been on SST for 180 days. For participants with local recurrence after curative-intent local therapy on imaging :

⁃ Patients with local recurrence in the prostate, SV, or prostate bed are eligible as long as there is at least 1 nodal or distant metastatic recurrence. Biopsy must confirm local recurrence for patients who have had prior curative-intent radiation to the prostate, SV, or prostate bed.

⁃ Candidate for salvage local therapy (refer to Section 10.4) as determined by a urologist or radiation oncologist (depending on the respective modality to be used to treat the local recurrence).

⁃ For participants with de novo prostate cancer:

⁃ Candidate for prostate-directed radiation.

Locations
United States
California
VA Long Beach Healthcare System, Long Beach, CA
RECRUITING
Long Beach
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
RECRUITING
West Los Angeles
Washington, D.c.
Washington DC VA Medical Center, Washington, DC
RECRUITING
Washington D.c.
Florida
Bay Pines VA Healthcare System, Pay Pines, FL
RECRUITING
Bay Pines
Illinois
Edward Hines Jr. VA Hospital, Hines, IL
RECRUITING
Hines
Indiana
Richard L. Roudebush VA Medical Center, Indianapolis, IN
RECRUITING
Indianapolis
Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
RECRUITING
Boston
Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
RECRUITING
Baltimore
Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
RECRUITING
Ann Arbor
Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
ACTIVE_NOT_RECRUITING
Minneapolis
Missouri
Kansas City VA Medical Center, Kansas City, MO
TERMINATED
Kansas City
North Carolina
Durham VA Medical Center, Durham, NC
RECRUITING
Durham
New Jersey
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
TERMINATED
East Orange
New York
VA NY Harbor Healthcare System, New York, NY
TERMINATED
New York
Ohio
Louis Stokes VA Medical Center, Cleveland, OH
RECRUITING
Cleveland
Pennsylvania
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
RECRUITING
Philadelphia
Texas
Michael E. DeBakey VA Medical Center, Houston, TX
RECRUITING
Houston
Virginia
Hunter Holmes McGuire VA Medical Center, Richmond, VA
RECRUITING
Richmond
Wisconsin
William S. Middleton Memorial Veterans Hospital, Madison, WI
RECRUITING
Madison
Clement J. Zablocki VA Medical Center, Milwaukee, WI
RECRUITING
Milwaukee
Contact Information
Primary
Abhishek Solanki, MD MS
Abhishek.Solanki@va.gov
(708) 202-8387
Time Frame
Start Date: 2021-07-01
Estimated Completion Date: 2029-03-30
Participants
Target number of participants: 464
Treatments
Active_comparator: Standard Systemic Therapy (SST)
All Veterans will receive SST (if De novo, Veterans will receive prostate-directed radiation).
Experimental: SST + PET-directed local therapy
In addition to SST, all Veterans will receive PET-directed local therapy to all metastases using surgery or radiation. If De novo, Veterans will also receive prostate-directed radiation or radical prostatectomy to treat the prostate/prostate bed. The best course of treatment will be determined using shared decision-making between the physician and Veteran.
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov