Study on Risk-Based Reduced Hormone Therapy with Radiation for Treating Prostate Cancer

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06369610

Provider View

This clinical trial is exploring whether using fewer hormone therapy treatments, based on individual risk, along with radiation can effectively treat prostate cancer. The study aims to see if this approach works as well as more extensive hormone therapy for high-risk patients.

Patient Parameters

Program Overview

This phase II study is testing a new approach to treating prostate cancer by using fewer hormone therapy treatments based on the patient's risk level, combined with radiation therapy. Hormone therapy, like androgen deprivation therapy (ADT), reduces testosterone levels, which may help stop cancer cells from growing. Radiation therapy uses high-energy rays to kill cancer cells. While long-term hormone therapy is known to help high-risk prostate cancer patients, this study investigates if a risk-based, reduced hormone therapy approach can be just as effective.

Description

The main goal of this study is to see if patients can return to their normal hormone levels within two years after treatment. Researchers will also look at other factors, such as side effects, quality of life, and cancer progression over five years.

Patients are divided into three groups based on their risk level:

  • Group I (Low Risk): Patients receive radiation therapy to the prostate area for 2 to 6 weeks.
  • Group II (Intermediate Risk): Patients receive hormone therapy injections for up to 12 months, unless the cancer progresses or side effects are too severe. Radiation therapy starts 8 to 10 weeks after beginning hormone therapy.
  • Group III (High Risk): Patients receive hormone therapy injections, with or without an additional drug called abiraterone acetate, for up to 18 months. Radiation therapy starts 8 to 10 weeks after beginning hormone therapy.

Throughout the study, patients will have imaging tests like PET, CT, or MRI scans, and blood samples will be collected. After treatment, patients will have follow-up visits at 3 and 12 months, then yearly for up to 5 years, and every 2 years after that.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with high-risk prostate cancer.
  • Cancer stages T1c-T4, N0-Nx-N1, M0-1.
  • At least one high-risk feature, such as Gleason score 8-10, stage T3-T4, or PSA level of 20 or higher.
  • Good overall health with an ECOG performance status of 0-2.
  • Must sign a consent form approved by the study's review board.
  • Must complete all required tests before starting the study.
  • Must be at least 18 years old.
  • Have oligometastatic prostate cancer, meaning cancer has spread to up to 5 distant or regional areas.

Exclusion Criteria

  • Previous radiation treatment to the pelvic area.
  • More than 6 months of prior hormone therapy for prostate cancer.
  • Active rectal conditions like diverticulitis or Crohn's disease affecting the rectum.
  • Previous chemotherapy for prostate cancer.
  • History of urethral stricture requiring treatment.
  • Currently taking blood thinners like warfarin or heparin, unless they can be stopped if needed.
  • Major medical, psychiatric, or addiction issues that could interfere with treatment or follow-up.
  • Any other cancer within the past 5 years with less than a 50% chance of 5-year survival, except for certain skin cancers.
  • Recent heart attack or severe heart failure within the last 6 months.

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