Actively Recruiting
Single-Dose Image-Guided Radiotherapy With Urethral Sparing and DIL Boost for Intermediate-Risk Prostate Cancer (PROSINT II)
Led by Fundacao Champalimaud · Updated on 2026-05-08
200
Participants Needed
1
Research Sites
604 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This prospective single-arm phase II study evaluates the safety, feasibility, quality-of-life effects, PSA kinetics, imaging response, and clinical outcomes of definitive ultra-high dose single-fraction external beam radiation therapy in patients with biopsy-proven NCCN intermediate-risk localized adenocarcinoma of the prostate. All eligible patients receive image-guided volumetric modulated arc radiotherapy with urethral sparing and organ-motion mitigation. Treatment consists of 24 Gy in one fraction to the whole prostate gland and proximal seminal vesicles. Patients with NCCN unfavorable intermediate-risk disease and an imaging-defined dominant intraprostatic lesion may receive a PSMA PET/CT-guided simultaneous integrated boost to the dominant intraprostatic lesion in sequential dose-escalation cohorts, up to 30 Gy, while maintaining protocol-defined organ-at-risk constraints. A rectal balloon with air filling is used for prostate target immobilization and anatomical reproducibility, and a urethral catheter loaded with beacon transponders is used to identify the urethra, support urethral sparing, and enable online target tracking. Toxicity is assessed using CTCAE v4.0, and patient-reported outcomes are assessed using EPIC-26, IPSS, and IIEF questionnaires. PSA is measured at protocol-defined follow-up visits. Multiparametric MRI is performed at baseline and at 12 and 24 months after treatment. Participants are followed for a minimum of 5 years.
CONDITIONS
Official Title
Single-Dose Image-Guided Radiotherapy With Urethral Sparing and DIL Boost for Intermediate-Risk Prostate Cancer (PROSINT II)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed study-specific informed consent form
- Histologic confirmation of adenocarcinoma of the prostate by biopsy
- Biopsy ISUP grade 1-3
- Biopsy-proven localized intermediate-risk prostate cancer according to NCCN criteria
- No previous hormonal therapy
- PSA C= 20 ng/mL
- Staging multiparametric MRI confirmation of AJCC cT1c-cT2c disease with no cT3, cT4, or N1 disease
- No direct evidence of regional or distant metastases after staging
- Age E= 18 years
- Performance status 0-2
- International Prostate Symptom Score (IPSS) C= 15; alpha-blockers allowed
- CT- or ultrasound-based prostate gland volume estimate C= 100 grams
You will not qualify if you...
- Positive lymph nodes or metastatic prostate cancer on imaging
- MRI evidence of radiographic T3, T4, or N1 disease
- Biopsy ISUP grade E 4
- Previous pelvic radiotherapy
- Previous prostate cancer surgery
- Previous transurethral resection of the prostate within 3 months
- Contraindication to Foley catheter, rectal balloon, MRI, PSMA PET/CT, or treatment immobilization/tracking
- Active urinary tract infection or unresolved acute prostatitis
- Previous hormonal therapy
- History of Crohn's disease or ulcerative colitis
- Previous significant obstructive symptoms
- Significant psychiatric illness
- CT- or ultrasound-estimated prostate volume E 100 grams
- Severe active comorbidity precluding treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Champalimaud Foundation
Lisbon, Portugal, 1400-038
Actively Recruiting
Research Team
C
Carlo Greco, MD
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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