Status:
RECRUITING
PRospective Observational Study of STereotactic Body rAdiation Therapy With Androgen Deprivation Therapy for Organ-confined High-risk Prostate Cancer: the PROSTAR Trial
Lead Sponsor:
Istituto Clinico Humanitas
Collaborating Sponsors:
accord healthcare italia srl
Conditions:
High Risk Prostate Cancer
Eligibility:
MALE
18+ years
Brief Summary
Prostate Cancer (PCa) is the second most common malignancy and the 5th common cause of cancer-related mortality in men worldwide. The majority of patients with PCa is diagnosed with potentially curabl...
Eligibility Criteria
Inclusion
- Age \> 18 years
- ECOG performance status ≤ 2
- Histologically proven prostate adenocarcinoma
- High-risk group classification according to National Comprehensive Cancer Network (NCCN), defined by the presence of any one of the following high-risk factors: cT3-cT4 OR Grade Group 4 or Grade Group 5 OR PSA \>20 ng/mL
- No pelvic nodal and distant metastases at staging with PSMA-PET
- IPSS ≤ 15 (alpha blockers allowed)
- Life expectancy of \> 5 years
- Prostate volume ≤ 100 cc
Exclusion
- Previous local radiation treatment of the prostate
- Previous radiotherapy to the pelvis
- Active Ulcerative Colitis or Crohn's Disease
- Previous tumors unless disease free for a minimum of 5 years
Key Trial Info
Start Date :
April 4 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2032
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT06949254
Start Date
April 4 2025
End Date
May 1 2032
Last Update
July 30 2025
Active Locations (3)
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1
Humanitas Gavazzeni
Bergamo, Bergamo, Italy, 24125
2
Humanitas PIO X
Milan, Milan, Italy, 20159
3
IRCCS Humanitas Research Hospital
Rozzano, Milan, Italy, 20089