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Higher dose radiation therapy for prostate cancer treatment

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

Phase 3 Interventional Canadian Cancer Trials Group · NCT06235697

This study tests if a higher dose of radiation given in a shorter time can work just as well as the usual treatment for men with tough-to-treat prostate cancer.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment710 (estimated)
Ages18 Years and up
SexMale
SponsorCanadian Cancer Trials Group Research network
Drugs / interventionschemotherapy, Radiation
Locations57 sites (Antioch, California and 56 other locations)
Trial IDNCT06235697 on ClinicalTrials.gov

What this trial studies

This study evaluates whether a higher dose of radiation therapy delivered over a shorter period using Stereotactic Body Radiation Therapy (SBRT) is as effective as the standard external beam radiation therapy combined with a brachytherapy boost for patients with unfavorable prostate cancer. The trial includes patients diagnosed with adenocarcinoma of the prostate within the last nine months and assesses various risk factors to determine eligibility. Participants will receive either SBRT alone or the standard treatment approach, with the goal of improving cancer control rates.

Who should consider this trial

Good fit: Ideal candidates are men aged 18 and older with histologically confirmed adenocarcinoma of the prostate and specific unfavorable risk factors.

Not a fit: Patients with favorable risk prostate cancer or those not medically fit for brachytherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more effective and efficient treatment option for patients with unfavorable prostate cancer.

How similar studies have performed: Other studies have shown promising results with similar high-dose radiation approaches, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Antioch, California and 56 other locations

+7 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Prostate Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.