Status:
RECRUITING
Two-fraction Versus Five-fraction Stereotactic Radiotherapy for Localized Prostate Cancer
Lead Sponsor:
Rabin Medical Center
Conditions:
PROSTATE CANCER
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to compare two dose schedules of stereotactic radiation therapy in patients with localized prostate cancer. Historically, external beam radiation to treat localized ...
Detailed Description
Following publication of multiple prospective clinical trials demonstrating the biochemical progression free survival (bPFS) benefits of high dose radiation for the curative treatment of localized pro...
Eligibility Criteria
Inclusion
- Inclusion:
- Male patients ≥18 years
- Diagnosis of low- or favorable intermediate-risk prostate adenocarcinoma
- T1-T2c
- Prostate specific antigen \< 20
- Gleason 6 or 7 (3+4)
- Cannot had multiple intermediate-risk factors consistent with unfavorable intermediate risk disease
- Prostate gland \< 60 cc (can include following cytoreductive androgen deprivation)
- International Prostate Symptom Score \< 15 (unaided by a-adrenergic inhibitor or anticholinergic drugs)
- Exclusion:
- Unfavorable intermediate-risk disease and above
- Chronic inflammatory bowel condition (IBD, Crohn's disease, Sarcoidosis, Rheumatic disease)
- Chronic immunosuppression
- Contraindications to hydrogel spacer placement
- Contraindications to a prostate MRI
- Any prior prostate cancer treatment
- Prior pelvic radiotherapy
- Previous transurethral resection of the prostate (TURP) within 12 months
- Hip prosthesis
- Prior use of therapeutic androgen deprivation therapy
Exclusion
Key Trial Info
Start Date :
December 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2032
Estimated Enrollment :
562 Patients enrolled
Trial Details
Trial ID
NCT06027892
Start Date
December 29 2022
End Date
December 1 2032
Last Update
November 15 2024
Active Locations (1)
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1
Davidoff Cancer Center, Rabin Medical Center
Petah Tikva, Israel, Israel, 49100