Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment

Description

This study is being done to answer the following question: Is the strategy to give higher doses of radiotherapy treatment over a shorter period of time using special equipment and fewer treatments (also known as Stereotactic Body Radiation Therapy or SBRT) as effective as usual external radiation therapy given with a brachytherapy boost (which involves radiation sources inserted directly into the prostate)?

Conditions

Prostate Cancer

Study Overview

Study Details

Study overview

This study is being done to answer the following question: Is the strategy to give higher doses of radiotherapy treatment over a shorter period of time using special equipment and fewer treatments (also known as Stereotactic Body Radiation Therapy or SBRT) as effective as usual external radiation therapy given with a brachytherapy boost (which involves radiation sources inserted directly into the prostate)?

Androgen Suppression Combined With Elective Nodal Irradiation and Dose Escalated Prostate Treatment: A Non-Inferiority, Phase III Randomized Controlled Trial of Stereotactic Body Radiation Therapy Versus Brachytherapy Boost in Patients With Unfavourable Risk Localized Prostate Cancer

Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Creve Coeur

Siteman Cancer Center at West County Hospital, Creve Coeur, Missouri, United States, 63141

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

Saint Louis

Siteman Cancer Center-South County, Saint Louis, Missouri, United States, 63129

Saint Louis

Siteman Cancer Center at Christian Hospital, Saint Louis, Missouri, United States, 63136

Saint Peters

Siteman Cancer Center at Saint Peters Hospital, Saint Peters, Missouri, United States, 63376

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 9 months
  • * Participants with unfavourable risk prostate cancer are eligible according to the following NCCN classification guidelines (Version 4.2022 - May 10, 2022):
  • * 2 or 3 Intermediate Risk Factors (IRFs): cT2b-cT2c, Gleason 7 (grade group 2 or 3), and/or PSA 10-20 ng/ml;
  • * Gleason 4+3 (grade group 3)
  • * \> 50% biopsy cores positive
  • * cT3a
  • * Gleason 8-10 (grade group 4 or 5)
  • * PSA \> 20 ng/ml
  • * cT3b-cT4
  • * Primary Gleason pattern 5
  • * 2 or 3 high risk features: cT3a, Gleason 8-10 (grade group 4 or 5), and/or PSA \> 20 ng/ml
  • * \> 4 cores with Gleason 8-10 (grade group 4 or 5)
  • * ECOG performance status of 0, 1 or 2
  • * Participants must be ≥ 18 years of age
  • * Judged to be medically fit for brachytherapy
  • * Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in either English, French or Spanish
  • * Participants consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrollment in the trial to document their willingness to participate
  • * Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up
  • * In accordance with CCTG policy, protocol treatment is to begin within 12 weeks of participant enrollment
  • * Participants must be willing to take precautions to prevent pregnancy while on study
  • * ADT (LHRH agonists, antagonists, or anti-androgens) for prostate cancer is permitted for up to 30 days before study enrollment
  • * 5-alpha reductase inhibitors (5-ARI) are allowed, but baseline PSA will be corrected if 5-ARI use occurs within 6 months of enrollment
  • * Participants may NOT have received other therapies including chemotherapy, PARPi, radioligand or other investigational drugs for prostate cancer
  • * Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • * Urinary function defined as International Prostate Symptom Score (IPSS) \< 20. Alpha blockers are allowed to treat baseline urinary function
  • * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • * Prior pelvic radiotherapy
  • * Contraindication to radical prostate radiotherapy (e.g. connective tissue disease or inflammatory bowel disease)
  • * Anticoagulation medication (if unsafe to discontinue for gold seed insertion or brachytherapy implant) and/or prior or current bleeding diathesis
  • * Prior steam vaporization (Rezum), transurethral resection of the prostate (TURP), prostatectomy (simple or radical), or any ablative therapy to the prostate (cryotherapy, HIFU, TULSA, focal laser ablation, photodynamic therapy)
  • * Prostate volume \> 60cc before start of androgen deprivation therapy
  • * Anatomy that would preclude precise brachytherapy implant (such as arch interference or large median lobe)
  • * Evidence of castrate resistance (defined as a rising PSA \> 3.0 ng/ml while testosterone is \< 3.0 nmol/l)
  • * Hip prosthesis

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Canadian Cancer Trials Group,

Andrew Loblaw, STUDY_CHAIR, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada

Study Record Dates

2033-04-30