Status:
RECRUITING
ABlative Radiotherapy (for) Unfavorable Prostate Tumors
Lead Sponsor:
University of Milano Bicocca
Conditions:
Prostate Cancer
Eligibility:
MALE
18-90 years
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 exp...
Detailed Description
Patients enrolled in this observational prospective trial will be offered image-guided, volumetric modulated radiotherapy (IGRT-VMAT) in a single session (SDRT) of 21 Gy to the whole gland with a simu...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- 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);
- EXCLUSION CRITERIA:
- ≥T3b disease according to the 8th AJCC classification;
- PSA\>20 ng/ml at any time point;
- Previous local treatment of the prostate with surgery (radical prostatectomy or cryotherapy);
- Previous radiotherapy to the pelvis;
- Previous invasive malignancy unless disease free for a minimum of 5 years;
- Active Crohn's Disease or Ulcerative Colitis;
Exclusion
Key Trial Info
Start Date :
April 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04831983
Start Date
April 15 2021
End Date
April 1 2029
Last Update
January 3 2024
Active Locations (1)
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1
Radiation Oncology, ASST Monza (University of Milan Bicocca)
Monza, MB, Italy, 20900