← Back to Search

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

Must not have

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)

Any known brain metastases, presence of leptomeningeal disease, malignant spinal cord compression, or malignant cauda equina syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My prostate cancer is resistant to hormone therapy, shown by rising PSA levels despite low testosterone.

Select...

I do not have brain metastases or specific malignant spinal conditions.

Select...

I need radiation therapy for cancer symptoms.

Select...

I have not had radiation that would make more treatment too risky.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Castration-resistant prostate cancer-free survival (CRPC-free survival)

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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).

0 / 5Eligibility criteria met