NCT04831983Recruiting
ABlative Radiotherapy (for) Unfavorable Prostate Tumors
Single-Dose Image-Guided Radiotherapy (IGRT) With Focal Boost to the MRI-defined Macroscopic Tumor Volume for Intermediate Unfavorable and High Risk Prostate Cancer
Source: ClinicalTrials.gov · Last updated 3 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 30 Mar 2021
- Start date
- 15 Apr 2021
- Primary completion date
- 1 Apr 2029
- Lead sponsor
- University of Milano Bicocca
- Diseases
- Prostate cancer
- NCT number
- NCT04831983
What you commit to
- Study type: Observational
- Planned participants: 30
- From 15 Apr 2021 to the primary completion date, 1 Apr 2029
- 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
- Previous local treatment of the prostate with surgery (radical prostatectomy or cryotherapy);
- Previous radiotherapy to the pelvis;
Other illness
- ≥T3b disease according to the 8th AJCC classification;
- Previous invasive malignancy unless disease free for a minimum of 5 years;
- Active Crohn's Disease or Ulcerative Colitis;
Other
- PSA\>20 ng/ml at any time point;
Who the study is looking for
- Histologically proven prostate adenocarcinoma;
- Intermediate and High risk disease, as per the NCCN definition;
- N0M0 at staging with standard techniques (Bone Scan and Abdominal CT) or (preferably) Choline or PSMA PET-CT;
- ECOG performance status between 0 and 2;
- Life expectancy of \> 5 years, in the opinion of the investigator;
- IPSS score must be ≤ 19 (alpha blockers allowed);
Age in the registry: 18 years to 90 years · 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 |
|---|---|---|---|
| Radiation Oncology, ASST Monza (University of Milan Bicocca) Coordinator of this site? Confirm its status | Monza | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.