Study on Combining Hormone Therapy with Targeted Radiation and Increased Dose Prostate Treatment

Sponsor: Canadian Cancer Trials Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06235697

Provider View

This clinical trial is exploring whether giving higher doses of radiation over a shorter time using special equipment is as effective as the usual radiation therapy combined with a direct prostate radiation boost for treating unfavorable prostate cancer.

Patient Parameters

Program Overview

The study aims to find out if using higher doses of radiation therapy over a shorter period, known as Stereotactic Body Radiation Therapy (SBRT), is as effective as the usual method of external radiation therapy with a brachytherapy boost, where radiation sources are placed directly into the prostate. This approach is being tested in patients with unfavorable prostate cancer to see if it can control the cancer as well as the standard treatment.

Description

Typically, patients with unfavorable prostate cancer who are not part of a study receive external beam radiation therapy (EBRT) to the pelvis and prostate along with hormone therapy (androgen deprivation therapy - ADT). To better control the cancer and reduce the risk of it returning, an additional brachytherapy boost is often recommended. In the usual treatment approach, about 89 out of 100 patients are free of cancer after 5 years.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate cancer within the last 9 months.
  • Classified as having unfavorable risk prostate cancer based on specific medical guidelines.
    • Unfavorable-intermediate risk includes:
      • 2 or 3 Intermediate Risk Factors: cT2b-cT2c, Gleason 7, and/or PSA 10-20 ng/ml.
      • Gleason 4+3.
      • More than 50% of biopsy cores positive.
    • High risk includes:
      • cT3a.
      • Gleason 8-10.
      • PSA greater than 20 ng/ml.
    • Very-high risk includes:
      • cT3b-cT4.
      • Primary Gleason pattern 5.
      • 2 or 3 high risk features.
      • More than 4 cores with Gleason 8-10.
  • ECOG performance status of 0, 1, or 2.
  • Aged 18 years or older.
  • Medically fit for brachytherapy.
  • Able to complete quality of life questionnaires in English, French, or Spanish.
  • Willing to sign a consent form and participate in the trial.
  • Available for treatment and follow-up.
  • Willing to take precautions to prevent pregnancy during the study.
  • ADT for prostate cancer is allowed for up to 30 days before enrollment.
  • 5-alpha reductase inhibitors are allowed with PSA correction if used within 6 months of enrollment.
  • No prior chemotherapy, PARPi, radioligand, or other investigational drugs for prostate cancer.
  • Other cancers that do not interfere with the study are allowed.
  • Urinary function score less than 20.
  • HIV-positive patients on effective therapy with undetectable viral load are eligible.

Exclusion Criteria

  • Previous pelvic radiotherapy.
  • Conditions that prevent safe prostate radiotherapy, like certain diseases.
  • Use of blood thinners that cannot be safely stopped.
  • Previous prostate surgeries or treatments like TURP or cryotherapy.
  • Prostate volume over 60cc before starting hormone therapy.
  • Anatomy that prevents precise brachytherapy.
  • Evidence of castrate resistance.
  • Hip prosthesis.

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