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Hormone Therapy
Systemic + Local Therapy for Prostate Cancer (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
ECOG Performance Status </= 2 at time of enrollment
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
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.
Who is the study for?
This trial is for veterans with oligorecurrent prostate cancer, who've had prior local treatment and are experiencing a rise in PSA indicating recurrence. They must be able to consent, have an ECOG Performance Status of 2 or less, and meet specific criteria regarding their initial cancer stage and treatments. Those already on systemic therapy can join if it's been less than 180 days.Check my eligibility
What is being tested?
The study tests whether adding PET-directed local therapy (radiation or surgery) to standard systemic therapy improves disease control in patients with recurring prostate cancer detected by PET/CT scans. It's a multi-institutional phase II/III randomized trial comparing two approaches.See study design
What are the potential side effects?
Potential side effects include those associated with hormone therapies like fatigue, hot flashes, sexual dysfunction; chemotherapy-related nausea, hair loss; radiation-induced skin changes; surgical risks such as bleeding and infection; plus any drug-specific reactions.
VA STARPORT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
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 moreVA STARPORT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SST + PET-directed local therapyExperimental Treatment12 Interventions
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.
Group II: Standard Systemic Therapy (SST)Active Control9 Interventions
All Veterans will receive SST (if De novo, Veterans will receive prostate-directed radiation).
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,304,820 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer spread to my lymph nodes, bones, or organs after treatment meant to cure it, which may not make me eligible for certain targeted therapies.My prostate cancer is resistant to hormone therapy, shown by rising PSA levels despite low testosterone.I do not have brain metastases or specific malignant spinal conditions.I have had cancer before, but it was either skin cancer, early-stage cancer in remission, or any cancer I've been free from for 3 years.I need radiation therapy for cancer symptoms.I have not had radiation that would make more treatment too risky.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.I can take care of myself and am up and about more than half of my waking hours.I had prostate cancer treated with the intent to cure and it might be coming back based on recent tests.
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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