Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment
ASCENDE-SBRT
2 other identifiers
interventional
710
2 countries
57
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)?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 prostate-cancer
Started Apr 2024
Typical duration for phase_3 prostate-cancer
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2024
CompletedFirst Posted
Study publicly available on registry
February 1, 2024
CompletedStudy Start
First participant enrolled
April 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2033
April 14, 2026
September 1, 2025
8.5 years
January 19, 2024
April 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
8.6 years
Secondary Outcomes (9)
Safety and tolerability assessed by CTCAE v5.0
8.6 years
PSA response at 4 years compared using a Cochran-Mantel-Haenszel (CMH) test
8.6 years
Metastasis-free Survival compared using the Gray's test
8.6 years
Cause-specific Survival compared using the Gray's test
8.6 years
Overall Survival analysed using a Cox proportional hazards model and graphically described using the Kaplan-Meier method
8.6 years
- +4 more secondary outcomes
Study Arms (2)
EBRT + Brachy Boost
ACTIVE COMPARATORSBRT
EXPERIMENTALInterventions
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
25Gy / 5 fractions to pelvis + 40 Gy / 5 fractions to prostate (SBRT) (ultrahypofractionation EBRT (SBRT))
Eligibility Criteria
You may qualify if:
- 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:
- 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
- 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)
- +14 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Canadian Cancer Trials Grouplead
- NRG Oncologycollaborator
Study Sites (57)
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531, United States
Kaiser Permanente Dublin
Dublin, California, 94568, United States
Kaiser Permanente-Fremont
Fremont, California, 94538, United States
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, 93720, United States
Kaiser Permanente-Fresno
Fresno, California, 93720, United States
Kaiser Permanente-Modesto
Modesto, California, 95356, United States
Kaiser Permanente Oakland-Broadway
Oakland, California, 94611, United States
Kaiser Permanente-Oakland
Oakland, California, 94611, United States
Kaiser Permanente- Marshall Medical Offices
Redwood City, California, 94063, United States
Kaiser Permanente-Richmond
Richmond, California, 94801, United States
Rohnert Park Cancer Center
Rohnert Park, California, 94928, United States
Kaiser Permanente-Roseville
Roseville, California, 95661, United States
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, 95678, United States
Kaiser Permanente Downtown Commons
Sacramento, California, 95814, United States
Kaiser Permanente-South Sacramento
Sacramento, California, 95823, United States
Kaiser Permanente-San Francisco
San Francisco, California, 94115, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, 95119, United States
Kaiser Permanente San Leandro
San Leandro, California, 94577, United States
Kaiser San Rafael-Gallinas
San Rafael, California, 94903, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051, United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403, United States
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, 94080, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, 94080, United States
Kaiser Permanente-Stockton
Stockton, California, 95210, United States
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, 95688, United States
Kaiser Permanente-Vallejo
Vallejo, California, 94589, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596, United States
Memorial Hospital East
Shiloh, Illinois, 62269, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129, United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042, United States
Manhattan Eye Ear and Throat Hospital
New York, New York, 10065, United States
Lenox Hill Hospital
New York, New York, 10075, United States
Saint Vincent Hospital
Erie, Pennsylvania, 16544, United States
Jefferson Hospital
Jefferson Hills, Pennsylvania, 15025, United States
Forbes Hospital
Monroeville, Pennsylvania, 15146, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
West Penn Hospital
Pittsburgh, Pennsylvania, 15224, United States
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania, 15090, United States
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, 23114, United States
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia, 23230, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
Doctor H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2, Canada
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7, Canada
Waterloo Regional Health Network
Kitchener, Ontario, N2G 1G3, Canada
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
Trillium Health Partners - Credit Valley Hospital
Mississauga, Ontario, L5M 2N1, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9, Canada
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Andrew Loblaw
Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2024
First Posted
February 1, 2024
Study Start
April 25, 2024
Primary Completion (Estimated)
October 31, 2032
Study Completion (Estimated)
April 30, 2033
Last Updated
April 14, 2026
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share