OncoMatch/Clinical Trials/NCT05851547
Dose Escalation For INtraprostatic LEsions
Is NCT05851547 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Triptorelin for prostatic neoplasms.
Treatment: Triptorelin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage UNFAVOURABLE INTERMEDIATE-RISK, HIGH-RISK LOCALIZED (AJCC)
Excluded: Stage T1-4 N1 M0-1, T1-4 N0 M1
Grade: Gleason 3+4 (grade group 2)Gleason 4+3 (grade group 3)Gleason ≥ 8 (grade group 4 or 5) (Gleason/ISUP grade group)
Unfavourable intermediate-risk or high-risk localized disease; definitions provided in criteria
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: androgen deprivation therapy (triptorelin, bicalutamide) — planned
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.
Cannot have received: androgen deprivation therapy
Exception: commenced more than 60 days prior to enrollment
Androgen deprivation therapy commenced more than 60 days prior to enrollment
Cannot have received: pelvic radiotherapy
Prior pelvic radiotherapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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