NCT07407608 ABlative Radiotherapy (for) Unfavorable Prostate Tumors 2.0
| NCT ID | NCT07407608 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Milano Bicocca |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 58 participants |
| Start Date | 2026-01-28 |
| Primary Completion | 2029-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 58 participants in total. It began in 2026-01-28 with a primary completion date of 2029-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Published clinical evidence confirms that a single dose of 24 Gy provides unprecedented long-term local control in primary and metastatic prostate cancer with safe toxicity profiles, provided that exposure of surrounding healthy tissues is critically assessed with fulfillment of strict constraints and dose distribution is accomplished using image guidance and tracking tools. In the present trial, intermediate unfavorable and selected high-risk organ-confined prostate cancer patients will undergo Single Dose Radiation Therapy (SDRT) With Focal Boost to the MRI-defined Macroscopic Tumor Volume by means of image-guided volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) and state-of-the-art treatment-planning and quality assurance procedures. Androgen Deprivation Therapy (ADT) type and duration has been set as per standard of care, in accordance with current recommendations and guidelines. The results of the study will enable us to find out if the new, shorter treatment (1 doses of radiotherapy), has a similar level of side effects as the 5 dose treatment and is suitable for further study.
Eligibility Criteria
Inclusion Criteria: * Histologically proven prostate adenocarcinoma; * Intermediate and High risk disease, as per the NCCN definition; * a PI-RADS 3-5 dominant intraprostatic lesion on multiparametric MRI (mpMRI); * N0M0 at staging with standard techniques (Bone Scan and Abdominal CT) or (preferably) PSMA PET-CT; * World Health Organization performance status 0-1; * Life expectancy of \> 5 years, in the opinion of the investigator; * IPSS score must be ≤ 15 (alpha blockers allowed); * Prostate gland volume ≤100 g as estimated by computed tomography (CT), ultrasound, or MRI. Exclusion Criteria: * ≥T3b disease according to the 8th AJCC classification; * PSA\>20 ng/ml; * Previous local treatment of the prostate with surgery (radical prostatectomy or cryotherapy) or transurethral resection; * Previous radiotherapy to the pelvis; * Presence of a periurethral dominant lesion; * Previous invasive malignancy unless disease free for a minimum of 5 years; * Active Crohn's Disease or Ulcerative Colitis; * Presence of hip prostheses.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07407608 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 90 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07407608 currently recruiting?
Yes, NCT07407608 is actively recruiting participants. Contact the research team at stefano.arcangeli@unimib.it for enrollment information.
Where is the NCT07407608 trial being conducted?
This trial is being conducted at Monza, Italy.
Who is sponsoring the NCT07407608 clinical trial?
NCT07407608 is sponsored by University of Milano Bicocca. The trial plans to enroll 58 participants.
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