NCT06235697 · Canadian Cancer Trials Group
Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment
(ASCENDE-SBRT)
What this study is about
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)?
View original scientific description
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)?
Interventions
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
RADIATION
Radiation SBRT only
25Gy / 5 fractions to pelvis + 40 Gy / 5 fractions to prostate (SBRT) (ultrahypofractionation EBRT (SBRT))
DRUG
ADT
Assigned at enrollment
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- Gleason 8-10 (grade group 4 or 5)
- PSA \> 20 ng/ml • Very-high risk - has at least one of the following:
- 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
Where
- Antioch, California
- Dublin, California
- Fremont, California
- Fresno, California
- Modesto, California
- Oakland, California
- Redwood City, California
- Richmond, California
- Rohnert Park, California
- Roseville, California
- Sacramento, California
- San Francisco, California
And 24 more locations — see the full list below.
Collaborators
NRG Oncology
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 14, 2026 · Source of record for eligibility and locations