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Hormone Therapy
Various Treatments for Prostate Cancer with Oligorecurrence(VA STARPORT Trial)
Phase 2 & 3
Recruiting
Led By Abhishek Solanki, MD MS
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prior localized prostate cancer, confirmed histologically or cytologically, and defined as: Any T-classification, Gleason Grade Group, and pre-treatment PSA at the time of initial curative-intent treatment are acceptable. Nx, N0, or N1 N-classification at the time of curative-intent local therapy. No metastatic disease at the time of initial curative-intent treatment are acceptable. If original documentation for Criteria 5.4.1, 5.4.2, and/or 5.4.3 is unavailable, documentation of localized prostate cancer or NCCN risk group satisfies these criteria. Prior curative-intent local therapy for localized prostate cancer with either upfront definitive radiotherapy or prostatectomy with or without post-operative radiotherapy. PSA suspicious for biochemical recurrence after local therapy, with lab value(s) taken within 90 days prior to enrollment or prior to start of SST (if current SST has already started), and meeting one of the three below categories: PSA >/= 0.2 ng/ml x 2 after prostatectomy +/- post-operative radiotherapy; or 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 and meets one of the criteria below. For patients who have a history of prior therapy with SST agents for prostate cancer, a total testosterone >/= 100 ng/dl after completion of prior SST and either before the start of current SST or within 30 days of starting current SST is also required if the patient has already started SST for recurrence. For patients who have no prior history 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 within 90 days prior to enrollment or prior to start of SST if already on SST for recurrence. 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. Technetium (Tc99m-MDP) or sodium fluoride (NaF) bone scan (sodium fluoride preferred) performed within 90 days prior to enrollment or prior to start of SST if already on SST for recurrence. This is optional for patients who have a PSMA PET/CT. FDA-approved standard of care PET/CT (currently PSMA, Fluciclovine, choline) performed within 90 days prior to enrollment or prior to start of SST if already on SST for recurrence. 1-5 lesions suspicious for nodal recurrence or metastasis from prostate cancer as determined by the investigator based on the above imaging studies. Per investigator determination, multiple lesions can be grouped as a single index lesion if in close proximity and considered a single treatment target. 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 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 as determined by a urologist or radiation oncologist (depending on the respective modality to be used to treat the local recurrence)
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up4 years
Awards & highlights
No Placebo-Only Group
VA STARPORT Trial Summary
This trial is testing whether adding PET-directed local therapy to standard systemic therapy improves disease control in Veterans with oligorecurrent prostate cancer.
Eligible Conditions
- Prostate Cancer
- Oligometastasis
- Oligorecurrence
VA STARPORT Trial Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have had localized prostate cancer in the past and have undergone treatment for it, but now have a recurrence of the cancer in certain areas of your body. You must have had certain imaging tests done within the past 90 days to confirm the recurrence and have a plan in place for genetic testing. You must also be a candidate for salvage therapy as determined by a urologist or radiation oncologist.
VA STARPORT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Castration-resistant prostate cancer-free survival (CRPC-free survival)
Secondary outcome measures
Clinical progression-free survival (cPFS)
Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 toxicity
Expanded Prostate cancer Index Composite Short Form (EPIC-26)
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
VA STARPORT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SST + PET-directed local therapyExperimental Treatment11 Interventions
In addition to SST, all Veterans will receive PET-directed local therapy to all metastases using surgery or radiation. The selection of surgery or radiation to each metastasis will be determined using shared decision-making between the physician and Veteran.
For Veterans with a local recurrence, this will be treated with salvage local therapy.
Group II: Standard Systemic Therapy (SST)Active Control8 Interventions
All Veterans will receive SST
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,584 Previous Clinical Trials
2,897,244 Total Patients Enrolled
14 Trials studying Prostate Cancer
8,321 Patients Enrolled for Prostate Cancer
Abhishek Solanki, MD MSPrincipal InvestigatorEdward Hines Jr. VA Hospital, Hines, IL
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a medical condition that might affect your ability to receive treatment or interfere with the study assessments, as determined by the investigator at the study site.You have cancer that has spread to other parts of your body, except for the areas that are being studied in this trial.You have had localized prostate cancer in the past and have undergone treatment for it, but now have a recurrence of the cancer in certain areas of your body. You must have had certain imaging tests done within the past 90 days to confirm the recurrence and have a plan in place for genetic testing. You must also be a candidate for salvage therapy as determined by a urologist or radiation oncologist.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Systemic Therapy (SST)
- Group 2: SST + PET-directed local therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical condition does SRT usually target?
"Salvage Local Therapy is an effective treatment for recurrent disease that manifests in the form of ulcerative colitis, varicella-zoster virus acute retinal necrosis, or a change in scalp structure."
Answered by AI
Are there other examples of research studies that focus on Salvage Local Therapy for treating cancer patients with recurring disease?
"Currently, there are 963 different clinical trials studying Salvage Local Therapy for recurrent disease. Of those studies, 308 are in the critical third phase. The largest number of these studies is based out of Sacramento, California; however, there are 51691 locations conducting research on this topic."
Answered by AI
how many different places are patients being recruited for this research?
"This trial has 18 enrolling patients, including at the Michael E. DeBakey VA Medical Center in Houston, TX; VA Pittsburgh Healthcare System University Drive Division in Pittsburgh, PA; and VA Long Beach Healthcare System in Long Beach, CA. There are also other locations with enrolling patients for this trial."
Answered by AI
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