MRI-guided Brachytherapy and Salvage SBRT Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brachytherapy and MR-Guided SBRT.
- Who it may be relevant to
- Registry conditions: Prostate Cancer (Post Prostatectomy). Basic parameters: 18 years — 80 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
MRI-guided Brachytherapy + Salvage SBRT Program for Patients With Prostate Bed Relapses After Radical Prostatectomy
Overview
Brachytherapy followed by MRI-guided irradiation has the potential to improve treatment results in patients with local relapses after radical prostatectomy
Detailed description
The goal of this clinical trial is to learn if the use of brachytherapy followed by MRI-guided irradiation increases the rates of tumor control and decreases the rates of adverse events in patients with tumor bed relapses after radical prostatectomy
Interventions
- Radiation Brachytherapy and MR-Guided SBRT
HDR Brachytherapy followed by MR-guided SBRT
Primary outcome measures
- Biochemical control [Time frame: 5-year]
- Adverse Events [Time frame: 5-year]
Secondary outcome measures (1)
- QOL [Time frame: From enrollment to extended follow-up at 5 years with QOL assessment at 3, 6, 12 months after treatment and yearly thereafter]
Eligibility criteria
Patients with increasing PSA after RP and clinical evidence of PET PSMA/Choline+ and RMN+ isolated prostatic bed relapse (IPBR) that is implantable via transperineal route . The IPBR should be visible on TRUS imaging to allow proper implant placement.
- Pathological confirmation is advised in all cases but it is not mandatory .
- Patients with any of the following were not considered eligible:
- Distance < 5mm from the edge of the IPBR to any of the defined OARs (UV anastomosis, rectal wall, bladder wall, external urinary sphincter)
- Distant Metastases
- Isolated nodal relapses
- Prior Irradiation to the IPBR area
- Multicentric IPBRs
- Life expectancy of less than 5 years or inability to tolerate and comply with an HDR procedure
- No prior radiation therapy to the target areas;
- Karnofsky performance status > 70 with medical condition not contraindicating treatment with radical intent including maximal TURBT and concomitant chemotherapy;
- WBC equal or greater than 3500 mm3; platelet count equal or greater than 135000 mm3; hemoglobin equal or greater than 10 gr/L; BUN equal or less than 20; serum creatinine equal or less than 2.0.
- Ability to undergo MRI scanning.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07132671 · 2024.224