Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.

Launched by JULES BORDET INSTITUTE · Jul 23, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for men with prostate cancer who have had surgery but are seeing signs of the disease returning. Specifically, the study is comparing a targeted type of radiation therapy called salvage stereotactic body radiotherapy (SBRT) to the usual care that patients receive when their prostate-specific antigen (PSA) levels are rising again after surgery. The goal is to see which approach is more effective in managing prostate cancer that has come back.

To participate in this trial, men must be between the ages of 65 and 74 and have had surgery for localized prostate cancer. They should have a detectable PSA level of at least 0.1 ng/mL at least six weeks after their surgery or show a pattern of rising PSA levels. However, there are certain conditions that may prevent someone from joining, such as having had more advanced cancer at the time of surgery or other significant health issues. If eligible, participants will receive detailed information about the study and will be asked to sign a consent form before starting. It's a chance to help advance treatment options for prostate cancer while receiving close monitoring and care.

Gender

MALE

Eligibility criteria

• • INCLUSION CRITERIA
• • 1. Localized adenocarcinoma (cN0M0) of the prostate treated primarily with radical prostatectomy with definitive intent.
• • 2. Either persistent PSA after prostatectomy (PSA ≥ 0.1 ng/mL at least 6 weeks after prostatectomy), or biochemical progression (two consecutive rising PSA amounts with a PSA \>0.1 ng/mL , or three consecutive PSA rises)
• • 3. WHO PS 0-1
• • 4. Age ≥18 years
• • 5. Ability to understand and willingness to sign a study-specific informed consent prior to study entry
• • 6. Ability to understand and answer the EPIC-26 form in one of the languages available
• • EXCLUSION CRITERIA
• • 1. Patients with a pT4 tumor at prostatectomy
• • 2. Patients with previously pathologically confirmed N1
• • 3. Patients with macroscopically involved margin at surgery (R2)
• • 4. Patients with a history of distant metastases
• • 5. Patients with a recurrence visible on imaging (local, pelvic, or distant). Pelvic nodes with a small diameter \>1cm and/or positive on PSMA without other explanation, are considered as a pelvic recurrence.
• • 6. Latest PSA \> 2ng/ml
• • 7. Patients with a IPSS \>20
• • 8. Gleason 10 tumor
• • 9. Prior history of high-intensity focused ultrasound ablation (HIFU), cryosurgery or brachytherapy of the prostate
• • 10. Prior pelvic radiotherapy
• • 11. Prior hormonal therapy started more than 6 weeks before randomization
• • 12. History of inflammatory bowel disease, ataxia telangiectasia, prior rectal or bladder surgery.
• • 13. Other active malignancy, except non-melanoma skin cancer, superficial bladder cancer, or malignancies with a documented disease-free survival for a minimum of 3 years before randomization.