Study on Standard Therapy With or Without PET-Directed Local Therapy for Veterans with Oligometastatic Prostate Cancer

Sponsor: VA Office of Research and Development

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04787744

Provider View

This clinical trial is exploring whether adding PET-directed local therapy to standard treatment can improve outcomes for Veterans with oligometastatic prostate cancer, which means having 1-10 sites of cancer spread.

Patient Parameters

Program Overview

This study aims to find out if adding PET-directed local therapy to standard systemic therapy (SST) can help Veterans with oligometastatic prostate cancer live longer without their cancer becoming resistant to treatment. Oligometastatic prostate cancer is when the cancer has spread to 1-10 areas. The trial will compare the effects of standard treatment alone versus standard treatment combined with PET-directed local therapy, which targets specific cancer sites using imaging techniques.

Description

Prostate cancer is the most common cancer among Veterans, making up 30% of new cancer cases in the VA. Most men have localized prostate cancer, treated with surveillance or local therapies like surgery or radiation. However, 20% of these men will see their cancer return and spread. They usually receive hormone therapy to manage the disease, but many will see their cancer progress within 1-2 years, and half may die within 5 years.

Recent studies have looked at two main approaches to improve survival in men with recurrent metastatic prostate cancer. One approach focuses on patients with oligometastatic disease, where the cancer has spread to a few sites. These patients might benefit from local treatments like surgery or radiation to all cancer sites, potentially leading to long-term control or even cure. Some trials have shown that this approach can improve survival without needing systemic therapy.

However, 75% of patients treated this way see new cancer areas develop, suggesting that systemic therapy is still needed. Studies show that starting hormone therapy earlier can improve survival. Another approach is to enhance hormone therapy by adding new drugs or chemotherapy, which has been shown to improve survival significantly. These drugs are now part of the standard treatment for metastatic prostate cancer.

This study aims to see if combining PET-directed local therapy with standard systemic therapy can further improve outcomes for Veterans with oligometastatic prostate cancer. The trial will also look at cancer progression patterns, survival, quality of life, and whether certain genetic mutations can predict who will benefit from the added local therapy.

Eligibility Criteria

Inclusion Criteria

  • Age 18 years or older.
  • Ability to provide informed consent.
  • ECOG Performance Status of 2 or better.
  • Confirmed prostate cancer diagnosis.
  • If cancer has returned, must have had prior local therapy aimed at curing the cancer.
  • PSA levels indicating cancer recurrence after local therapy.
  • Serum testosterone levels checked before starting current treatment.
  • Imaging tests done before starting current treatment.
  • 1-10 suspicious lesions for cancer spread.
  • Plan for genetic sequencing of the cancer.
  • For those already on treatment, must have been on it for 180 days.
  • Eligible for additional local therapy if cancer has returned locally.
  • Eligible for prostate-directed radiation if newly diagnosed.

Exclusion Criteria

  • Evidence of castration-resistant prostate cancer.
  • History of another cancer, unless it was non-melanoma skin cancer, early-stage cancer in remission, or cancer-free for three years.
  • Symptomatic metastasis needing palliative radiotherapy.
  • Known brain metastases or certain spinal conditions.
  • Previous metastasis after curative therapy that disqualifies PET-directed local therapy.
  • Prior radiation to areas needing local therapy that poses high risk of side effects.
  • Any condition that may interfere with the study treatments or assessments.

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