Recruiting

Phase 3

SBRT vs. BrachytherapyAndrogen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment

Sponsor:

Canadian Cancer Trials Group

Code:

NCT06235697

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiation

Radiation SBRT only

ADT

Study Details

Brief 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)?

Conditions

Prostate Cancer

Study ID

NCT06235697

Start date

Apr 25, 2024

Status verified date

Sep, 2025

Completion date

Apr 30, 2033

Anticipated

Primary completion date

Oct 31, 2032

Anticipated

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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):

• 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

Exclusion Criteria:

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 (unilateral hip replacement is allowed if dose constrains can be reasonably achieved.

Study Design

Enrollment

710 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: EBRT + Brachy Boost

experimental: SBRT

Interventions

Radiation

46Gy / 23 fractions of EBRT to pelvis and prostate + LDR or HDR boost to prostate OR 25Gy / 5 fractions of EBRT to pelvis and prostate (ultrahypofractionation EBRT (SBRT)) + LDR or HDR boost to prostate.

\+ Adjuvant ADT: Unfavourable Intermediate Risk: 6 months or High / Very High Risk: 24 months

Radiation SBRT only

25Gy / 5 fractions to pelvis + 40 Gy / 5 fractions to prostate (SBRT) (ultrahypofractionation EBRT (SBRT))

ADT

Assigned at enrollment

Primary outcome measure

To compare the progression-free survival (PFS) of SBRT versus conventional EBRT plus brachytherapy boost defined as time to biochemical failure, initiation of salvage therapy, local-regional recurrence, distant progression, or death [ Time Frame: 8.6 years ]

Central Contacts and Locations

Central contacts

Wendy Parulekar

613-533-6430 wparulekar@ctg.queensu.ca

Locations

Kaiser Permanente-Deer Valley Medical Center

Recruiting

Antioch, California, United States, 94531

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente Dublin

Recruiting

Dublin, California, United States, 94568

Contacts

Site Public Contact

877-642-4691

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-Fremont

Recruiting

Fremont, California, United States, 94538

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente Fresno Orchard Plaza

Recruiting

Fresno, California, United States, 93720

Contacts

Site Public Contact

833-574-2273

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-Fresno

Recruiting

Fresno, California, United States, 93720

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-Modesto

Recruiting

Modesto, California, United States, 95356

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente Oakland-Broadway

Recruiting

Oakland, California, United States, 94611

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-Oakland

Recruiting

Oakland, California, United States, 94611

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente- Marshall Medical Offices

Recruiting

Redwood City, California, United States, 94063

Contacts

Site Public Contact

877-642-4691

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-Richmond

Recruiting

Richmond, California, United States, 94801

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Rohnert Park Cancer Center

Recruiting

Rohnert Park, California, United States, 94928

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-Roseville

Recruiting

Roseville, California, United States, 95661

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

The Permanente Medical Group-Roseville Radiation Oncology

Recruiting

Roseville, California, United States, 95678

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente Downtown Commons

Recruiting

Sacramento, California, United States, 95814

Contacts

Site Public Contact

877-642-4691 kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-South Sacramento

Recruiting

Sacramento, California, United States, 95823

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-San Francisco

Recruiting

San Francisco, California, United States, 94115

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-Santa Teresa-San Jose

Recruiting

San Jose, California, United States, 95119

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente San Leandro

Recruiting

San Leandro, California, United States, 94577

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser San Rafael-Gallinas

Recruiting

San Rafael, California, United States, 94903

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente Medical Center - Santa Clara

Recruiting

Santa Clara, California, United States, 95051

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-Santa Rosa

Recruiting

Santa Rosa, California, United States, 95403

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente Cancer Treatment Center

Recruiting

South San Francisco, California, United States, 94080

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-South San Francisco

Recruiting

South San Francisco, California, United States, 94080

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-Stockton

Recruiting

Stockton, California, United States, 95210

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente Medical Center-Vacaville

Recruiting

Vacaville, California, United States, 95688

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-Vallejo

Recruiting

Vallejo, California, United States, 94589

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-Walnut Creek

Recruiting

Walnut Creek, California, United States, 94596

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Memorial Hospital East

Recruiting

Shiloh, Illinois, United States, 62269

Contacts

Site Public Contact

314-747-9912 dschwab@wustl.edu

Principal Investigator:

Lannis E. Hall

Siteman Cancer Center at Saint Peters Hospital

Recruiting

City of Saint Peters, Missouri, United States, 63376

Contacts

Site Public Contact

800-600-3606 info@siteman.wustl.edu

Principal Investigator:

Lannis E. Hall

Siteman Cancer Center at West County Hospital

Recruiting

Creve Coeur, Missouri, United States, 63141

Contacts

Site Public Contact

800-600-3606 info@siteman.wustl.edu

Principal Investigator:

Lannis E. Hall

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Site Public Contact

800-600-3606 info@siteman.wustl.edu

Principal Investigator:

Lannis E. Hall

Siteman Cancer Center-South County

Recruiting

St Louis, Missouri, United States, 63129

Contacts

Site Public Contact

800-600-3606 info@siteman.wustl.edu

Principal Investigator:

Lannis E. Hall

Siteman Cancer Center at Christian Hospital

Recruiting

St Louis, Missouri, United States, 63136

Contacts

Site Public Contact

800-600-3606 info@siteman.wustl.edu

Principal Investigator:

Lannis E. Hall

Billings Clinic Cancer Center

Recruiting

Billings, Montana, United States, 59101

Contacts

Site Public Contact

800-996-2663 research@billingsclinic.org

Principal Investigator:

John M. Schallenkamp

Northwell Health/Center for Advanced Medicine

Recruiting

Lake Success, New York, United States, 11042

Contacts

Site Public Contact

516-734-8896

Principal Investigator:

Sang E. Sim

Manhattan Eye Ear and Throat Hospital

Recruiting

New York, New York, United States, 10065

Contacts

Site Public Contact

212-434-4460

Principal Investigator:

Sang E. Sim

Lenox Hill Hospital

Recruiting

New York, New York, United States, 10075

Contacts

Site Public Contact

516-734-8896

Principal Investigator:

Sang E. Sim

Saint Vincent Hospital

Recruiting

Erie, Pennsylvania, United States, 16544

Contacts

Site Public Contact

814-452-5000

Principal Investigator:

Zachary Horne

Jefferson Hospital

Recruiting

Jefferson Hills, Pennsylvania, United States, 15025

Contacts

Site Public Contact

412-359-3043 ddefazio@wpahs.org

Principal Investigator:

Zachary Horne

Forbes Hospital

Recruiting

Monroeville, Pennsylvania, United States, 15146

Contacts

Site Public Contact

412-858-7746

Principal Investigator:

Zachary Horne

Allegheny General Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Site Public Contact

877-284-2000

Principal Investigator:

Zachary Horne

West Penn Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Site Public Contact

412-578-5000

Principal Investigator:

Zachary Horne

Wexford Health and Wellness Pavilion

Recruiting

Wexford, Pennsylvania, United States, 15090

Contacts

Site Public Contact

Dawnmarie.DeFazio@ahn.org

Principal Investigator:

Zachary Horne

Bon Secours Saint Francis Medical Center

Recruiting

Midlothian, Virginia, United States, 23114

Contacts

Site Public Contact

804-893-8978 anne_carmellat@bshsi.org

Principal Investigator:

Joseph D. Pennington

Bon Secours Cancer Institute at Reynolds Crossing

Recruiting

Richmond, Virginia, United States, 23230

Contacts

Site Public Contact

804-893-8978 Anne_caramella@bshsi.org

Principal Investigator:

Joseph D. Pennington

VCU Massey Comprehensive Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Site Public Contact

804-628-6430 CTOclinops@vcu.edu

Principal Investigator:

Alfredo I. Urdaneta

Doctor H. Bliss Murphy Cancer Centre

Recruiting

St. John's, Newfoundland and Labrador, Canada, A1B 3V6

Contacts

Site Public Contact

709-777-7589

Principal Investigator:

Asim Kamran

Royal Victoria Regional Health Centre

Recruiting

Barrie, Ontario, Canada, L4M 6M2

Contacts

Site Public Contact

705-739-5661

Principal Investigator:

Adam Gladwish

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Contacts

Site Public Contact

613-549-6666 cc-clinicaltrials@kgh.kari.net

Principal Investigator:

Martin Korzeniowski

Waterloo Regional Health Network

Recruiting

Kitchener, Ontario, Canada, N2G 1G3

Contacts

Site Public Contact

519-749-4370 research@wrhn.ca

Principal Investigator:

Darindra D. Gopaul

London Regional Cancer Program

Recruiting

London, Ontario, Canada, N6A 4L6

Contacts

Site Public Contact

519-685-8600

Principal Investigator:

Lucas C. Mendez

Trillium Health Partners - Credit Valley Hospital

Recruiting

Mississauga, Ontario, Canada, L5M 2N1

Contacts

Site Public Contact

905-813-4040

Principal Investigator:

Jasper Yuen

Lakeridge Health Oshawa

Recruiting

Oshawa, Ontario, Canada, L1G 2B9

Contacts

Site Public Contact

905-576-8711

Principal Investigator:

Audrey Li

Odette Cancer Centre- Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Site Public Contact

416-480-5000

Principal Investigator:

Douglas Andrew B. Loblaw

University Health Network-Princess Margaret Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Site Public Contact

416-946-4501 clinical.trials@uhn.on.ca

Principal Investigator:

Rachel M. Glicksman

CHUM - Centre Hospitalier de l'Universite de Montreal

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Contacts

Site Public Contact

514-890-8000 info.cr.chum@ssss.gouv.qc.ca

Principal Investigator:

Maroie Barkati

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Site Public Contact

514-340-8222

Principal Investigator:

Mohammad T. Niazi

More Information

Sponsor

Canadian Cancer Trials Group

Last update posted

Apr 14, 2026

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Canadian Cancer Trials Group on 2026-04-14.