Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment (ASCENDE-SBRT)

April 13, 2026 updated by: Canadian Cancer Trials Group

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

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)?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The usual approach for patients with unfavourable prostate cancer who are not in a study is treatment with external beam radiation therapy (EBRT) to the pelvis and prostate in combination with hormone therapy (androgen deprivation therapy - ADT). To improve control of prostate cancer at risk of returning, additional treatment with a brachytherapy boost (insertion of radiation sources directly into the prostate) is recommended. For patients who get the usual approach for this cancer, about 89 out of 100 are free of cancer after 5 years.

Study Type

Interventional

Enrollment (Estimated)

710

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Recruiting
        • Doctor H. Bliss Murphy Cancer Centre
        • Contact:
          • Site Public Contact
          • Phone Number: 709-777-7589
        • Principal Investigator:
          • Asim Kamran
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Recruiting
        • Royal Victoria Regional Health Centre
        • Contact:
          • Site Public Contact
          • Phone Number: 705-739-5661
        • Principal Investigator:
          • Adam Gladwish
      • Kingston, Ontario, Canada, K7L 2V7
        • Recruiting
        • Kingston Health Sciences Centre
        • Principal Investigator:
          • Martin Korzeniowski
        • Contact:
      • Kitchener, Ontario, Canada, N2G 1G3
        • Recruiting
        • Waterloo Regional Health Network
        • Contact:
        • Principal Investigator:
          • Darindra D. Gopaul
      • London, Ontario, Canada, N6A 4L6
        • Recruiting
        • London Regional Cancer Program
        • Contact:
          • Site Public Contact
          • Phone Number: 519-685-8600
        • Principal Investigator:
          • Lucas C. Mendez
      • Mississauga, Ontario, Canada, L5M 2N1
        • Recruiting
        • Trillium Health Partners - Credit Valley Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 905-813-4040
        • Principal Investigator:
          • Jasper Yuen
      • Oshawa, Ontario, Canada, L1G 2B9
        • Recruiting
        • Lakeridge Health Oshawa
        • Contact:
          • Site Public Contact
          • Phone Number: 4258 905-576-8711
        • Principal Investigator:
          • Audrey Li
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Odette Cancer Centre- Sunnybrook Health Sciences Centre
        • Contact:
          • Site Public Contact
          • Phone Number: 416-480-5000
        • Principal Investigator:
          • Douglas Andrew B. Loblaw
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • University Health Network-Princess Margaret Hospital
        • Contact:
        • Principal Investigator:
          • Rachel M. Glicksman
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 8248 514-340-8222
        • Principal Investigator:
          • Mohammad T. Niazi
      • Montreal, Quebec, Canada, H2X 3E4
        • Recruiting
        • CHUM - Centre Hospitalier de l'Universite de Montreal
        • Contact:
        • Principal Investigator:
          • Maroie Barkati
  • United States
    • California
      • Antioch, California, United States, 94531
        • Recruiting
        • Kaiser Permanente-Deer Valley Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Dublin, California, United States, 94568
        • Recruiting
        • Kaiser Permanente Dublin
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
        • Principal Investigator:
          • Samantha A. Seaward
      • Fremont, California, United States, 94538
        • Recruiting
        • Kaiser Permanente-Fremont
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Fresno, California, United States, 93720
        • Recruiting
        • Kaiser Permanente-Fresno
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Fresno, California, United States, 93720
        • Recruiting
        • Kaiser Permanente Fresno Orchard Plaza
        • Principal Investigator:
          • Samantha A. Seaward
        • Contact:
          • Site Public Contact
          • Phone Number: 833-574-2273
      • Modesto, California, United States, 95356
        • Recruiting
        • Kaiser Permanente-Modesto
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Oakland, California, United States, 94611
        • Recruiting
        • Kaiser Permanente-Oakland
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Oakland, California, United States, 94611
        • Recruiting
        • Kaiser Permanente Oakland-Broadway
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Redwood City, California, United States, 94063
        • Recruiting
        • Kaiser Permanente- Marshall Medical Offices
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
        • Principal Investigator:
          • Samantha A. Seaward
      • Richmond, California, United States, 94801
        • Recruiting
        • Kaiser Permanente-Richmond
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Rohnert Park, California, United States, 94928
        • Recruiting
        • Rohnert Park Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Roseville, California, United States, 95661
        • Recruiting
        • Kaiser Permanente-Roseville
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Roseville, California, United States, 95678
        • Recruiting
        • The Permanente Medical Group-Roseville Radiation Oncology
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Sacramento, California, United States, 95814
        • Recruiting
        • Kaiser Permanente Downtown Commons
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Sacramento, California, United States, 95823
        • Recruiting
        • Kaiser Permanente-South Sacramento
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • San Francisco, California, United States, 94115
        • Recruiting
        • Kaiser Permanente-San Francisco
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • San Jose, California, United States, 95119
        • Recruiting
        • Kaiser Permanente-Santa Teresa-San Jose
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • San Leandro, California, United States, 94577
        • Recruiting
        • Kaiser Permanente San Leandro
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • San Rafael, California, United States, 94903
        • Recruiting
        • Kaiser San Rafael-Gallinas
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Santa Clara, California, United States, 95051
        • Recruiting
        • Kaiser Permanente Medical Center - Santa Clara
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Kaiser Permanente-Santa Rosa
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • South San Francisco, California, United States, 94080
        • Recruiting
        • Kaiser Permanente-South San Francisco
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • South San Francisco, California, United States, 94080
        • Recruiting
        • Kaiser Permanente Cancer Treatment Center
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Stockton, California, United States, 95210
        • Recruiting
        • Kaiser Permanente-Stockton
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Vacaville, California, United States, 95688
        • Recruiting
        • Kaiser Permanente Medical Center-Vacaville
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Vallejo, California, United States, 94589
        • Recruiting
        • Kaiser Permanente-Vallejo
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Walnut Creek, California, United States, 94596
        • Recruiting
        • Kaiser Permanente-Walnut Creek
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
    • Illinois
      • Shiloh, Illinois, United States, 62269
        • Recruiting
        • Memorial Hospital East
        • Contact:
        • Principal Investigator:
          • Lannis E. Hall
    • Missouri
      • City of Saint Peters, Missouri, United States, 63376
        • Recruiting
        • Siteman Cancer Center at Saint Peters Hospital
        • Contact:
        • Principal Investigator:
          • Lannis E. Hall
      • Creve Coeur, Missouri, United States, 63141
        • Recruiting
        • Siteman Cancer Center at West County Hospital
        • Contact:
        • Principal Investigator:
          • Lannis E. Hall
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Lannis E. Hall
      • St Louis, Missouri, United States, 63129
        • Recruiting
        • Siteman Cancer Center-South County
        • Contact:
        • Principal Investigator:
          • Lannis E. Hall
      • St Louis, Missouri, United States, 63136
        • Recruiting
        • Siteman Cancer Center at Christian Hospital
        • Contact:
        • Principal Investigator:
          • Lannis E. Hall
    • Montana
      • Billings, Montana, United States, 59101
        • Recruiting
        • Billings Clinic Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
    • New York
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Northwell Health/Center for Advanced Medicine
        • Contact:
          • Site Public Contact
          • Phone Number: 516-734-8896
        • Principal Investigator:
          • Sang E. Sim
      • New York, New York, United States, 10075
        • Recruiting
        • Lenox Hill Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 516-734-8896
        • Principal Investigator:
          • Sang E. Sim
      • New York, New York, United States, 10065
        • Recruiting
        • Manhattan Eye Ear and Throat Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 212-434-4460
        • Principal Investigator:
          • Sang E. Sim
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16544
        • Recruiting
        • Saint Vincent Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 814-452-5000
        • Principal Investigator:
          • Zachary Horne
      • Jefferson Hills, Pennsylvania, United States, 15025
        • Recruiting
        • Jefferson Hospital
        • Contact:
        • Principal Investigator:
          • Zachary Horne
      • Monroeville, Pennsylvania, United States, 15146
        • Recruiting
        • Forbes Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 412-858-7746
        • Principal Investigator:
          • Zachary Horne
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • West Penn Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 412-578-5000
        • Principal Investigator:
          • Zachary Horne
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny General Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 877-284-2000
        • Principal Investigator:
          • Zachary Horne
      • Wexford, Pennsylvania, United States, 15090
        • Recruiting
        • Wexford Health and Wellness Pavilion
        • Contact:
        • Principal Investigator:
          • Zachary Horne
    • Virginia
      • Midlothian, Virginia, United States, 23114
        • Recruiting
        • Bon Secours Saint Francis Medical Center
        • Contact:
        • Principal Investigator:
          • Joseph D. Pennington
      • Richmond, Virginia, United States, 23230
        • Recruiting
        • Bon Secours Cancer Institute at Reynolds Crossing
        • Contact:
        • Principal Investigator:
          • Joseph D. Pennington
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • VCU Massey Comprehensive Cancer Center
        • Principal Investigator:
          • Alfredo I. Urdaneta
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SBRT
Radiation: Radiation SBRT only
25Gy / 5 fractions to pelvis + 40 Gy / 5 fractions to prostate (SBRT) (ultrahypofractionation EBRT (SBRT))
Active Comparator: EBRT + Brachy Boost
Drug: ADT
Assigned at enrollment
Other Names:
  • Androgen Deprivation Therapy
Radiation: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
8.6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability assessed by CTCAE v5.0
Time Frame: 8.6 years
8.6 years
PSA response at 4 years compared using a Cochran-Mantel-Haenszel (CMH) test
Time Frame: 8.6 years
8.6 years
Metastasis-free Survival compared using the Gray's test
Time Frame: 8.6 years
8.6 years
Cause-specific Survival compared using the Gray's test
Time Frame: 8.6 years
8.6 years
Overall Survival analysed using a Cox proportional hazards model and graphically described using the Kaplan-Meier method
Time Frame: 8.6 years
8.6 years
Participant-reported outcomes using EPIC-26 questionnaire
Time Frame: 8.6 years
8.6 years
Participant-reported tolerability using PRO-CTCAE questionnaire
Time Frame: 8.6 years
8.6 years
Economic Outcomes using EQ-5D-5L
Time Frame: 8.6 years
Canadian sites only
8.6 years
Economic Outcomes using FACIT-COST
Time Frame: 8.6 years
Canadian sites only
8.6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canadian Cancer Trials Group

Collaborators

NRG Oncology

Investigators

  • Study Chair: Andrew Loblaw, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2024

Primary Completion (Estimated)

October 31, 2032

Study Completion (Estimated)

April 30, 2033

Study Registration Dates

First Submitted

January 19, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

February 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCTG-PR24 (Other Identifier: NCI/CTEP)
  • NCI-2023-09091 (Other Identifier: NCI CTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual patient data may be shared once the final analysis is complete following the Canadian Cancer Trials Group Data Sharing Policy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on ADT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe