Prostate CancerPhase 3ASCENDE-SBRTNCT06235697
Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment
A Phase 3 study testing Radiation, Radiation SBRT only and ADT in people with Prostate Cancer, run by Canadian Cancer Trials Group at 57 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Radiation, Radiation SBRT only and ADT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 710 participants
- Where
- 57 sitesin 2 countries
- Study dates
- 25 Apr 2024to 30 Apr 2033
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 29Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
57 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
57 sites in 2 countries
United States46 sites, 46 recruiting
- Recruiting
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Lannis E. Hall
- Recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Lannis E. Hall
- Recruiting
Kaiser Permanente Dublin
Dublin, California, 94568
Site Public Contact, 877-642-4691
Samantha A. Seaward
- Recruiting
Saint Vincent Hospital
Erie, Pennsylvania, 16544
Site Public Contact, 814-452-5000
Zachary Horne
- Recruiting
Kaiser Permanente-Fremont
Fremont, California, 94538
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, 93720
Site Public Contact, 833-574-2273
Samantha A. Seaward
- Recruiting
Kaiser Permanente-Fresno
Fresno, California, 93720
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Jefferson Hospital
Jefferson Hills, Pennsylvania, 15025
Site Public Contact, 412-359-3043, ddefazio@wpahs.org
Zachary Horne
- Recruiting
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
Site Public Contact, 516-734-8896
Sang E. Sim
- Recruiting
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, 23114
Site Public Contact, 804-893-8978, anne_carmellat@bshsi.org
Joseph D. Pennington
- Recruiting
Kaiser Permanente-Modesto
Modesto, California, 95356
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Forbes Hospital
Monroeville, Pennsylvania, 15146
Site Public Contact, 412-858-7746
Zachary Horne
- Recruiting
Manhattan Eye Ear and Throat Hospital
New York, New York, 10065
Site Public Contact, 212-434-4460
Sang E. Sim
- Recruiting
Lenox Hill Hospital
New York, New York, 10075
Site Public Contact, 516-734-8896
Sang E. Sim
- Recruiting
Kaiser Permanente Oakland-Broadway
Oakland, California, 94611
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente-Oakland
Oakland, California, 94611
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Site Public Contact, 877-284-2000
Zachary Horne
- Recruiting
West Penn Hospital
Pittsburgh, Pennsylvania, 15224
Site Public Contact, 412-578-5000
Zachary Horne
- Recruiting
Kaiser Permanente- Marshall Medical Offices
Redwood City, California, 94063
Site Public Contact, 877-642-4691
Samantha A. Seaward
- Recruiting
Kaiser Permanente-Richmond
Richmond, California, 94801
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia, 23230
Site Public Contact, 804-893-8978, Anne_caramella@bshsi.org
Joseph D. Pennington
- Recruiting
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
Site Public Contact, 804-628-6430, CTOclinops@vcu.edu
Alfredo I. Urdaneta
- Recruiting
Rohnert Park Cancer Center
Rohnert Park, California, 94928
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente-Roseville
Roseville, California, 95661
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, 95678
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente Downtown Commons
Sacramento, California, 95814
Site Public Contact, 877-642-4691, kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente-South Sacramento
Sacramento, California, 95823
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente-San Francisco
San Francisco, California, 94115
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, 95119
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente San Leandro
San Leandro, California, 94577
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser San Rafael-Gallinas
San Rafael, California, 94903
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Memorial Hospital East
Shiloh, Illinois, 62269
Site Public Contact, 314-747-9912, dschwab@wustl.edu
Lannis E. Hall
- Recruiting
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, 94080
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente-South San Francisco
South San Francisco, California, 94080
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Lannis E. Hall
- Recruiting
Siteman Cancer Center-South County
St Louis, Missouri, 63129
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Lannis E. Hall
- Recruiting
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Lannis E. Hall
- Recruiting
Kaiser Permanente-Stockton
Stockton, California, 95210
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, 95688
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente-Vallejo
Vallejo, California, 94589
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596
Site Public Contact, 877-642-4691, Kpoct@kp.org
Samantha A. Seaward
- Recruiting
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania, 15090
Site Public Contact, Dawnmarie.DeFazio@ahn.org
Zachary Horne
Canada11 sites, 11 recruiting
- Recruiting
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2
Site Public Contact, 705-739-5661
Adam Gladwish
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Site Public Contact, 613-549-6666, cc-clinicaltrials@kgh.kari.net
Martin Korzeniowski
- Recruiting
Waterloo Regional Health Network
Kitchener, Ontario, N2G 1G3
Site Public Contact, 519-749-4370, research@wrhn.ca
Darindra D. Gopaul
- Recruiting
London Regional Cancer Program
London, Ontario, N6A 4L6
Site Public Contact, 519-685-8600
Lucas C. Mendez
- Recruiting
Trillium Health Partners - Credit Valley Hospital
Mississauga, Ontario, L5M 2N1
Site Public Contact, 905-813-4040
Jasper Yuen
- Recruiting
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4
Site Public Contact, 514-890-8000 ext. 12725, info.cr.chum@ssss.gouv.qc.ca
Maroie Barkati
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Site Public Contact, 514-340-8222 ext. 8248
Mohammad T. Niazi
- Recruiting
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9
Site Public Contact, 905-576-8711 ext. 4258
Audrey Li
- Recruiting
Doctor H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, A1B 3V6
Site Public Contact, 709-777-7589
Asim Kamran
- Recruiting
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Site Public Contact, 416-480-5000
Douglas Andrew B. Loblaw
- Recruiting
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Site Public Contact, 416-946-4501, clinical.trials@uhn.on.ca
Rachel M. Glicksman
About this study
Official title: 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)?
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Radiation, Radiation SBRT only, ADT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
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 onlyRadiation
25Gy / 5 fractions to pelvis + 40 Gy / 5 fractions to prostate (SBRT) (ultrahypofractionation EBRT (SBRT))
ADTDrug
Also called Androgen Deprivation Therapy
Assigned at enrollment
| Study group | Role | What they receive |
|---|---|---|
| EBRT + Brachy Boost | Active comparator | Not described Receives: Radiation: Radiation; Drug: ADT |
| SBRT | Experimental | Not described Receives: Radiation: Radiation SBRT only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8.6 years
Secondary outcomes (9)
Safety and tolerability assessed by CTCAE v5.0
Measured: 8.6 years
PSA response at 4 years compared using a Cochran-Mantel-Haenszel (CMH) test
Measured: 8.6 years
Metastasis-free Survival compared using the Gray's test
Measured: 8.6 years
Cause-specific Survival compared using the Gray's test
Measured: 8.6 years
Overall Survival analysed using a Cox proportional hazards model and graphically described using the Kaplan-Meier method
Measured: 8.6 years
Participant-reported outcomes using EPIC-26 questionnaire
Measured: 8.6 years
Participant-reported tolerability using PRO-CTCAE questionnaire
Measured: 8.6 years
Economic Outcomes using EQ-5D-5L
Canadian sites only
Measured: 8.6 years
Economic Outcomes using FACIT-COST
Canadian sites only
Measured: 8.6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start25 Apr 2024
- Primary completion31 Oct 2032 (estimated)
- Study completion30 Apr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Canadian Cancer Trials GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 710 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Cancer Trials Group
- Sponsor type
- Research network
- Collaborators
- NRG Oncology
- Responsible party
- Sponsor
- Investigators
- Andrew Loblaw, Study chair, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235697
- Sponsor's protocol ID
- CCTG-PR24
- Other IDs
- NCI-2023-09091, CCTG-PR24
- Acronym
- ASCENDE-SBRT
- Status last verified
- Sep 2025
- First submitted
- 19 Jan 2024
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06235697
- Acronym / sponsor ID
- ASCENDE-SBRT / CCTG-PR24
- Conditions
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 710 participants (estimated)
- Lead sponsor
- Canadian Cancer Trials GroupResearch network
- Collaborators
- NRG Oncology
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 31 Oct 2032 (estimated)
- Study completion
- 30 Apr 2033 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)?
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EBRT + Brachy Boost | Active comparator | Radiation: Radiation, Drug: ADT |
| SBRT | Experimental | Radiation: Radiation SBRT only |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation46Gy / 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 | EBRT + Brachy Boost |
| Radiation SBRT only25Gy / 5 fractions to pelvis + 40 Gy / 5 fractions to prostate (SBRT) (ultrahypofractionation EBRT (SBRT)) | Radiation | SBRT |
| ADTAlso: Androgen Deprivation TherapyAssigned at enrollment | Drug | EBRT + Brachy Boost |
Primary outcome
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
9 secondary outcomes
Safety and tolerability assessed by CTCAE v5.0
Time frame: 8.6 years
PSA response at 4 years compared using a Cochran-Mantel-Haenszel (CMH) test
Time frame: 8.6 years
Metastasis-free Survival compared using the Gray's test
Time frame: 8.6 years
Cause-specific Survival compared using the Gray's test
Time frame: 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
Participant-reported outcomes using EPIC-26 questionnaire
Time frame: 8.6 years
Participant-reported tolerability using PRO-CTCAE questionnaire
Time frame: 8.6 years
Economic Outcomes using EQ-5D-5L
Time frame: 8.6 years
Economic Outcomes using FACIT-COST
Time frame: 8.6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Loblaw study chair
Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada
57 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiation, Radiation SBRT only and ADT in people with Prostate Cancer, run by Canadian Cancer Trials Group at 57 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wendy Parulekar (613-533-6430, wparulekar@ctg.queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.