Actively Recruiting
Dose Escalation For INtraprostatic LEsions
Led by Ottawa Hospital Research Institute · Updated on 2024-01-05
54
Participants Needed
1
Research Sites
236 weeks
Total Duration
On this page
Sponsors
O
Ottawa Hospital Research Institute
Lead Sponsor
K
Knight Therapeutics (USA) Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
External beam radiotherapy combined with androgen deprivation therapy is a standard treatment option for localized prostate cancer. The current standard involves delivering radiotherapy uniformly throughout the prostate gland in daily fractions, five days per week, for approximately four weeks. In this study, radiotherapy will be delivered using an ultra-hypofractionated approach in three larger fractions on alternating days over one week Multiparametric magnetic resonance imaging will be used to guide focal dose escalation to parts of the gland harboring tumor, which could potentially reduce the risk of cancer recurrence compared to standard dose of radiotherapy. The aim of this study is to confirm that this approach can be delivered safely, that is, with rates of urinary and bowel side effects at 1 year of follow-up that are not significantly greater than the current standard.
CONDITIONS
Official Title
Dose Escalation For INtraprostatic LEsions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma of the prostate
- Unfavourable intermediate-risk or high-risk localized prostate cancer
- Unfavourable intermediate-risk defined as intermediate-risk with no high-risk features and one or more intermediate-risk factors including T2b-T2c, Gleason 3+4 or 4+3, or PSA 10-20 bcg/L, plus additional intermediate-risk factors
- High-risk defined as T3a-T3b; Gleason bc 8; or PSA > 20 bcg/L
- 3 Tesla prostate MRI performed within 12 months before enrollment
- ECOG performance status 0-2
- Age 18 years or older
- Written informed consent provided
- Planned androgen deprivation therapy with up to 6 months of triptorelin (with or without bicalutamide) for intermediate-risk or up to 24 months for high-risk prostate cancer
- Completion of all appropriate investigations before enrollment
You will not qualify if you...
- Evidence of pelvic nodal or distant metastases
- Discordance between prostate MRI and biopsy showing Gleason bc 4+3 adenocarcinoma without matching tumor on MRI
- Androgen deprivation therapy started more than 60 days before enrollment
- Planned elective radiotherapy to pelvic lymph nodes
- Other active malignancy within the past 3 years except treated skin carcinoma or low-grade bladder carcinoma
- Prior pelvic radiotherapy
- Contraindication to pelvic radiotherapy
- Any history of inflammatory bowel disease
- Unilateral or bilateral hip replacement
- Trans-urethral resection of the prostate (TURP) within 6 months before radiotherapy
- Concurrent participation in other therapeutic prostate cancer trials
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
Research Team
S
Scott Grimes
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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