Focal dose escalation for localized prostate cancer treatment
A Phase II Study of the Use of MRI-defined Focal Boosts With Stereotactic Body Radiotherapy for Localized Prostate Cancer
This study is testing a new way to treat localized prostate cancer by giving higher doses of radiation in a shorter time while also using hormone therapy to see if it works better and causes fewer side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Ottawa Hospital Research Institute Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT05851547 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a new approach to treating localized prostate cancer by using ultra-hypofractionated external beam radiotherapy combined with androgen deprivation therapy. The study aims to deliver radiotherapy in larger doses over a shorter period, guided by multiparametric magnetic resonance imaging to target tumor areas more effectively. By focusing the treatment on specific lesions within the prostate, the researchers hope to improve treatment efficacy while minimizing side effects compared to the standard uniform irradiation method. The trial will assess the safety and side effects of this innovative approach over a one-year follow-up period.
Who should consider this trial
Good fit: Ideal candidates include men aged 18 and older with histologically confirmed adenocarcinoma of the prostate classified as unfavorable intermediate-risk or high-risk localized disease.
Not a fit: Patients with low-risk prostate cancer or those who do not meet the specific eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could reduce the risk of cancer recurrence while maintaining a similar safety profile to current standard therapies.
How similar studies have performed: Previous studies have shown promise for ultra-hypofractionated approaches in treating localized prostate cancer, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate * Unfavourable intermediate-risk or high-risk localized disease * Unfavourable intermediate-risk prostate cancer is defined as intermediate-risk prostate cancer \[that is, no high-risk features and one or more intermediate-risk factors: T2b-T2c, Gleason 3+4 (grade group 2) or Gleason 4+3 (grade group 3), or PSA 10-20 μg/L\] and one or more of the following: 2 or 3 intermediate-risk factors; Gleason 4+3 (grade group 3); ≥ 50% biopsy cores positive * High-risk localized prostate cancer is defined as at least one of the following: T3a-T3b; Gleason ≥ 8 (grade group 4 or grade group 5); PSA \> 20 μg/L * 3 Tesla prostate MRI done no more than 12 months prior to enrollment * ECOG performance status 0-2 * Age ≥ 18 years * Written informed consent * The participant has planned androgen deprivation therapy that meets one of the following criteria: * Patients with intermediate-risk localized prostate cancer who have planned androgen deprivation therapy consisting of up to 6 months of triptorelin with or without bicalutamide; OR patients with high-risk localized prostate cancer who have planned androgen deprivation therapy consisting of up to 24 months of triptorelin with or without bicalutamide. * Completion of all appropriate investigations prior to enrollment Exclusion Criteria: * Evidence of pelvic nodal metastases or distant metastases (AJCC Stage T1-4 N1 M0-1 or T1-4 N0 M1 disease) * Discordance between pre-enrollment prostate MRI and prostate biopsy findings, defined as biopsy cores with Gleason Gleason ≥ 4+3 (grade group ≥ 3) adenocarcinoma with no corresponding tumour focus seen on MRI * Androgen deprivation therapy commenced more than 60 days prior to enrollment * Intention to electively treat the pelvic lymph nodes with radiotherapy * Other active malignancy within the previous three years (except adequately treated nonmelanomatous carcinoma of the skin or low-grade superficial bladder carcinoma) * Prior pelvic radiotherapy * Contraindication to pelvic radiotherapy * Any history, past or present, of inflammatory bowel disease * Unilateral or bilateral hip arthroplasty * Trans-urethral resection of the prostate (TURP) performed within 6 months of anticipated start date of radiotherapy * Patients must not concurrently participate in any other therapeutic prostate cancer trial.
Where this trial is running
Ottawa, Ontario
- The Ottawa Hospital Cancer Centre — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Scott C Morgan, MD, MSc — The Ottawa Hospital Cancer Centre
- Study coordinator: Scott Grimes
- Email: sgrimes@ohri.ca
- Phone: 613-737-7700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.