Prostate Cancer (Post Prostatectomy)
Conditions
Keywords
Prostate Cancer, Prostate Bed Relapse, Brachytherapy, MR-Guided SBRT
Brief summary
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
RADIATIONBrachytherapy and MR-Guided SBRT
HDR Brachytherapy followed by MR-guided SBRT
Sponsors
Clinica Universidad de Navarra, Universidad de Navarra
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion 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. 1. Pathological confirmation is advised in all cases but it is not mandatory . 2. Patients with any of the following were not considered eligible: 1. Distance \< 5mm from the edge of the IPBR to any of the defined OARs (UV anastomosis, rectal wall, bladder wall, external urinary sphincter) 2. Distant Metastases 3. Isolated nodal relapses 4. Prior Irradiation to the IPBR area 5. Multicentric IPBRs 6. Life expectancy of less than 5 years or inability to tolerate and comply with an HDR procedure 3. No prior radiation therapy to the target areas; 4. Karnofsky performance status \> 70 with medical condition not contraindicating treatment with radical intent including maximal TURBT and concomitant chemotherapy; 5. 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. 6. Ability to undergo MRI scanning.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical control | 5-year | To achieve 5-year biochemical control rate in 85% of the patients. |
| Adverse Events | 5-year | To decrease urinary grade 3 or greater toxicity below 3% and rectal grade 3 or greater toxicity below 1%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QOL | From enrollment to extended follow-up at 5 years with QOL assessment at 3, 6, 12 months after treatment and yearly thereafter | Determination of QOL with the EORTC QLQ-PR25 |
Contacts
Primary ContactBeatriz Ramos Aguirre, M.S.
Outcome results
None listed