Study on PSMA-Directed Radiation Therapy for Recurrent Prostate Cancer

Sponsor: University of Miami

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06392295

This clinical trial is exploring the use of targeted radiation therapy to improve control of prostate cancer that has returned in a limited area. The study also aims to maintain quality of life and use advanced imaging techniques to monitor the disease.

Patient Parameters

Program Overview

The purpose of this study is to investigate whether using radiation therapy directed at specific lymph nodes, along with hormone therapy, can better control prostate cancer that has returned in a limited area. The study also focuses on maintaining quality of life after treatment and using advanced imaging techniques, like PSMA PET/CT scans, to track the cancer's progress.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 or older with confirmed prostate cancer.
  • Cancer that has returned in a limited area below the diaphragm, possibly involving pelvic lymph nodes.
    • No more than 5 cancer spots on a PSMA PET/CT scan.
    • Cancer must be confined to pelvic and para-aortic lymph nodes below the diaphragm.
    • At least one cancer spot in the para-aortic lymph nodes below the diaphragm.
    • Tumors must be smaller than 5 cm.
  • Previous pelvic radiation treatment with a positive response.
    • Radiation to the prostate, with or without pelvic lymph nodes, or
    • Radiation to the prostate bed after surgery, with or without pelvic lymph nodes.
  • Cancer must be sensitive to hormone therapy.
  • General health status allowing normal activities or some restrictions (ECOG score 0-2).
  • Ability to understand the study and willingness to sign consent forms.
  • Willingness to complete quality of life and psychosocial questionnaires.
  • Willingness to participate in the Prostate Cancer Database Protocol.

Exclusion Criteria

  • No confirmed diagnosis of prostate cancer.
  • More than 5 cancer spots.
  • History of cancer spread to bones or organs.
  • No cancer in the para-aortic lymph nodes.
  • No PSMA PET/CT scan for staging.
  • Previous radiation outside the pelvis for prostate cancer.
  • Tumors larger than 5 cm.
  • Recent hormone or chemotherapy treatment before staging scan or study enrollment.
  • Suspicious cancer in the prostate without a negative biopsy.
  • Medical implants that interfere with treatment.
  • Prostate cancer that does not respond to hormone therapy.
  • Poor general health status (ECOG score greater than 2).
  • History of inflammatory bowel disease.
  • History of other cancers, except non-melanoma skin cancer.
  • Inability to consent or being a prisoner.
  • Unwillingness to complete quality of life and psychosocial questionnaires.
  • Impaired decision-making ability.

Get This Program In Your Inbox

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