Study on Genomic Biomarker-Selected Treatment Before Surgery for High-Risk Localized Prostate Cancer

Sponsor: University of British Columbia

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04812366

Provider View

This clinical trial is exploring whether using genomic testing to guide treatment can improve outcomes for men with high-risk localized prostate cancer. Participants will receive hormone therapy and apalutamide while their tumor's genetic profile is analyzed to determine the best treatment plan before surgery.

Patient Parameters

Program Overview

The study aims to find out if tailoring treatment based on the genetic makeup of prostate cancer tumors can lead to better responses in men with high-risk localized prostate cancer. Initially, all participants will receive hormone therapy and apalutamide for 8 weeks while their tumor samples are analyzed. Depending on the genetic results, participants will be assigned to different treatment groups, which may include additional medications like abiraterone acetate, prednisone, docetaxel, or niraparib. The study will assess how well these treatments work before participants undergo prostate surgery.

Description

This study involves multiple centers and has several treatment groups. Initially, all participants will receive hormone therapy (LHRHa) and apalutamide for at least 8 weeks while their tumor's genetic profile is analyzed. This analysis is done by a specialized lab using advanced techniques to identify specific genetic changes in the cancer cells.

If the tumor sample is not suitable for genetic testing, participants will continue with the initial treatment for an additional 16 weeks before surgery. For those with suitable samples, the genetic results will determine which treatment group they join. Each group will receive different combinations of medications for 16 weeks before surgery.

  • Group 1: For tumors with certain genetic changes, participants will receive either hormone therapy and apalutamide alone or with additional medications like abiraterone acetate and prednisone.
  • Group 2: For tumors with loss of specific tumor suppressor genes, participants will receive hormone therapy with abiraterone acetate and prednisone, with or without docetaxel.
  • Group 3: For tumors with DNA repair gene changes, participants will receive hormone therapy with abiraterone acetate, prednisone, and a PARP inhibitor (niraparib).
  • Group 4: For tumors with specific genetic instability, participants will receive hormone therapy with apalutamide and a PD-L1 inhibitor (atezolizumab).

The study will evaluate how well these treatments work in shrinking the cancer before surgery.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 years or older.
  • Diagnosed with prostate cancer that is high-risk but localized, based on specific medical criteria.
  • Willing to undergo genetic testing of their tumor.
  • No previous treatment for prostate cancer, except for up to 30 days of hormone therapy.
  • Good overall health with a life expectancy of at least 3 years.
  • Willing to provide informed consent and follow study procedures.

Exclusion Criteria

  • More than 30 days of hormone therapy before starting the study.
  • Advanced prostate cancer that has spread beyond the prostate.
  • Low testosterone levels or severe hormone deficiency.
  • Serious medical conditions that could pose safety risks or interfere with study procedures.
  • Inability to swallow pills or have digestive issues affecting medication absorption.
  • Allergies to study medications.
  • History of not following medical advice.
  • Previous treatments like hormone therapy, chemotherapy, surgery, or radiation for prostate cancer.
  • Currently taking or recently took certain hormone-related medications.
  • Cancer that has spread to other parts of the body as shown by standard imaging tests.

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