Status:
UNKNOWN
HDR Brachytherapy vs SABR in Early-intermediate Prostate Cancer
Lead Sponsor:
N.N. Petrov National Medical Research Center of Oncology
Conditions:
Biochemical Relapse Free Survival
Complications Rates (Erectile Dysfunction, GI, GU Complications)
Eligibility:
MALE
18-90 years
Phase:
NA
Brief Summary
This is single center prospective phase 2 randomized trial aiming to compare biochemical and clinical relapse free survival and toxicity profiles of stereotactic body radiotherapy (SBRT) versus high d...
Detailed Description
Before SBRT three fiducial markers are obligatory inserted into the prostate. Simulation and every SBRT sessions are performed after bowel preparation (enema) and bladder filling (400ml).Planning MRI ...
Eligibility Criteria
Inclusion
- WHO performance status of 0-2,
- histologically confirmed prostate adenocarcinoma: Gleason score - 6-7 (4+3), clinical stage T1c-T2c, N0, M0
- T and N stage determined by clinical examinations, MRI and/or PET-CT with PSMA
- PSA below 20 ng/ml within the last 30 days
- international prostate index score (IPSS) below 16
- medically fit to spinal anesthesia
- prostate volume below 110 cm³
- maximal urinary rate above 9 ml/sec, residual urine volume below 30ml,
- in the case of previous transurethral resection interval of at least 9 months after procedure.
Exclusion
- stage T3-T4,
- PSA \> 20 ng/ml,
- clinically detected lymph node or distant metastases,
- previous pelvic irradiation,
- rectal surgery.
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT04870567
Start Date
April 1 2018
End Date
April 1 2025
Last Update
May 3 2021
Active Locations (1)
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1
Sergey Novikov
Saint Petersburg, Russia, 197758