NCT05851547RecruitingPhase 2
Dose Escalation For INtraprostatic LEsions
A Phase II Study of the Use of MRI-defined Focal Boosts With Stereotactic Body Radiotherapy for Localized Prostate Cancer
Source: ClinicalTrials.gov · Last updated 5 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- First submitted
- 21 Mar 2023
- Start date
- 23 Nov 2023
- Primary completion date
- Jun 2027
- Lead sponsor
- Ottawa Hospital Research Institute
- Diseases
- Prostate cancer
- NCT number
- NCT05851547
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 54
- From 23 Nov 2023 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Trans-urethral resection of the prostate (TURP) performed within 6 months of anticipated start date of radiotherapy
Other illness
- Evidence of pelvic nodal metastases or distant metastases (AJCC Stage T1-4 N1 M0-1 or T1-4 N0 M1 disease)
- Any history, past or present, of inflammatory bowel disease
- Patients must not concurrently participate in any other therapeutic prostate cancer trial.
Other
- 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
- Unilateral or bilateral hip arthroplasty
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Ottawa Hospital Cancer Centre Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.