Study on Using POSLUMA Imaging to Improve Radiation Treatment for Prostate Cancer

Sponsor: Martin T. King, MD, PhD

Sponsor score: 0

ClinicalTrials ID:NCT07393867

This study is for men with intermediate or high-risk prostate cancer who are receiving hormone and radiation therapy. It aims to see if a special imaging test during hormone therapy can help doctors target cancer more accurately with radiation, potentially reducing side effects.

Patient Parameters

Program Overview

This research is focused on men with intermediate or high-risk prostate cancer who are undergoing hormone therapy and radiation treatment. The study aims to find out if a special imaging test, done during hormone therapy, can help doctors better target the remaining cancer with radiation, while avoiding areas that may not need extra treatment. All participants will receive standard hormone and radiation therapy, along with three imaging scans over six months. The goal is to make prostate cancer radiation treatment more precise and reduce side effects for future patients.

Description

Prostate cancer is often treated with hormone therapy and radiation. Hormone therapy lowers testosterone levels, which can shrink or weaken the cancer before radiation starts. However, after hormone therapy begins, it can be difficult for doctors to see where the active cancer is using standard imaging like MRI. This study is testing whether a newer imaging test can better identify which parts of the cancer are still active and might need more focused radiation treatment.

Participants will receive six months of hormone therapy, which is standard for intermediate and high-risk prostate cancer. They will also have PSMA PET/CT scans, a type of imaging that highlights prostate cancer cells, and MRI scans. These scans will be done before hormone therapy starts, about eight weeks after starting hormone therapy (before planning radiation), and again at 24 weeks (at the end of all treatment) to see how the cancer has responded.

Radiation therapy will start shortly after the eight-week imaging scan. Participants will receive high-precision radiation to the prostate over about two weeks. Based on the imaging results, doctors may give an extra "boost" of radiation to small areas that still show signs of active cancer. If the scans show that the cancer has responded well to hormone therapy, some patients may not need this extra boost. This approach aims to deliver the strongest treatment where needed while limiting radiation to healthy tissue to minimize side effects.

The main goal is to see if doctors can use the mid-treatment PSMA PET/CT scan to guide radiation planning. Researchers will also monitor changes in PSA blood levels, imaging findings, treatment side effects, and patient-reported quality of life, including urinary, bowel, and sexual symptoms. Doctors will provide feedback on how easy or difficult it is to define radiation target areas using the different scans.

Participation lasts about 6 months, and all treatments are commonly used in prostate cancer care, with the PSMA PET scans being the experimental part. While participants may or may not directly benefit, the study results may help improve how radiation therapy is planned and delivered for future prostate cancer patients, aiming to maintain treatment effectiveness while reducing side effects.

Eligibility Criteria

Inclusion Criteria

  • 18 years of age and older.
  • Good overall health with an Eastern Oncology Group Status of 0 to 1.
  • Diagnosed with prostate cancer.
  • Had a prior MRI showing at least one significant lesion within 180 days of screening.
  • Classified as intermediate or high-risk prostate cancer.
  • Had a prior PSMA PET scan showing at least one significant lesion matching the MRI within 180 days of screening.
  • Plan to receive high-precision radiation therapy with a possible extra boost to a specific lesion.

Exclusion Criteria

  • Previous imaging showing cancer spread to lymph nodes or distant areas.
  • Plan to receive additional treatments like certain hormone blockers or chemotherapy.
  • Advanced prostate cancer (clinical T4 disease).
  • Previous hormone therapy.
  • Previous radiation to the pelvic area.
  • Previous prostate surgery, including TURP.
  • High prostate symptom score (>20).
  • Previous urethral stricture.
  • Large prostate volume (>80 cc on MRI).
  • Hip implants causing imaging issues over the prostate.
  • Inability to stop blood thinners for marker placement.
  • Active Crohn's disease or scleroderma.

Locations

FACILITYZIPCITYSTATE
Brigham and Women's Hospital02115BostonMassachusetts
Dana Farber Cancer Institute02115BostonMassachusetts
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center01757MilfordMassachusetts
Dana-Farber/Brigham and Women's Cancer Center in Clinical Affiliation with South Shore Hospital02190WeymouthMassachusetts

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