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

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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)?

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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):

• • Unfavourable-intermediate risk - has one or more of the following:

• 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

• • High risk - has one of the following:

• cT3a

• Gleason 8-10 (grade group 4 or 5)

• PSA \> 20 ng/ml

• • Very-high risk - has at least one of the following:

• 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

Locations
United States
Missouri
Siteman Cancer Center at Saint Peters Hospital
RECRUITING
City Of Saint Peters
Siteman Cancer Center at West County Hospital
RECRUITING
Creve Coeur
Siteman Cancer Center at Christian Hospital
RECRUITING
St Louis
Siteman Cancer Center-South County
RECRUITING
St Louis
Washington University School of Medicine
RECRUITING
St Louis
Virginia
Bon Secours Saint Francis Medical Center
RECRUITING
Midlothian
Bon Secours Cancer Institute at Reynolds Crossing
RECRUITING
Richmond
Virginia Commonwealth University/Massey Cancer Center
RECRUITING
Richmond
Other Locations
Canada
Trillium Health Partners - Credit Valley Hospital
RECRUITING
Mississauga
Jewish General Hospital
RECRUITING
Montreal
Lakeridge Health Oshawa
RECRUITING
Oshawa
Odette Cancer Centre- Sunnybrook Health Sciences Centre
RECRUITING
Toronto
University Health Network-Princess Margaret Hospital
RECRUITING
Toronto
Contact Information
Primary
Wendy Parulekar
wparulekar@ctg.queensu.ca
613-533-6430
Time Frame
Start Date: 2024-04-25
Estimated Completion Date: 2033-04-30
Participants
Target number of participants: 710
Treatments
Active_comparator: EBRT + Brachy Boost
Experimental: SBRT
Related Therapeutic Areas
Sponsors
Collaborators: NRG Oncology
Leads: Canadian Cancer Trials Group

This content was sourced from clinicaltrials.gov