Study on PSMA-targeted Therapy and Hormone Suppression for Low-volume Metastatic Prostate Cancer: SPARKLE Trial

Sponsor: Mayo Clinic

Sponsor score: 60

ClinicalTrials ID:NCT07650240

Provider View

This clinical trial is exploring a new treatment approach for prostate cancer that has spread to a few areas or has returned after treatment. The study compares standard hormone therapy alone to a combination with a targeted radiotherapy drug, with or without additional medications, to see if it improves outcomes for patients.

Patient Parameters

Program Overview

This phase II study is testing different treatment combinations for prostate cancer that has spread to a limited number of areas or has come back after treatment. The trial compares the effects of leuprolide acetate, a hormone therapy, alone versus in combination with a targeted radiotherapy drug called 177Lu-PSMA-617. Some patients will also receive additional medications, abiraterone acetate and prednisone, to see if these combinations are more effective than hormone therapy alone. Leuprolide acetate works by reducing testosterone levels, which can slow the growth of prostate cancer cells. 177Lu-PSMA-617 targets and destroys cancer cells by delivering radiation directly to them. Abiraterone acetate blocks the production of male hormones, and prednisone helps manage side effects. The study aims to determine if these combinations can better treat patients with low-volume metastatic hormone-sensitive prostate cancer.

Eligibility Criteria

Inclusion Criteria

  • Male patients aged 18 years or older
  • Must provide signed informed consent before participating
  • Confirmed diagnosis of prostate cancer
  • Previous treatment with surgery or radiation for localized prostate cancer
  • Previous hormone therapy or chemotherapy allowed if:
    • Last treatment was over 12 months ago
    • Treatment lasted less than 3 months with no disease progression
  • Cancer detected on a specific type of scan (PSMA PET/CT) showing limited spread
  • Cancer must be hormone-sensitive and have spread to a limited number of areas
  • Good overall health with a performance status score of 0 to 2
  • Adequate blood counts and organ function based on specific tests
  • Able to start treatment within 28 days of screening
  • Expected to live more than 6 months

Exclusion Criteria

  • Cancer not detectable on PSMA PET/CT scan
  • Cancer spread that does not show PSMA markers on imaging
  • Cancer recurrence in the prostate area after initial treatment
  • Cancer spread to the spine causing compression
  • Previous progression on hormone therapy
  • Recent hormone therapy or chemotherapy within 12 months
  • Severe dry mouth or history of blood or kidney issues
  • Other cancers that affect life expectancy or interfere with assessment
  • Expected to live less than 6 months
  • Serious medical conditions that could affect participation
  • Male participants with female partners must use effective birth control during and for 14 weeks after the study

Locations

FACILITYZIPCITYSTATE
Mayo Clinic in Rochester55905RochesterMinnesota

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.