Trial of Ultrahypofractionated Focal Salvage Radiotherapy for Isolated Prostate Bed Recurrence After Radical Prostatectomy

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Feb 16, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for men with recurrent prostate cancer that has come back in the area where the prostate used to be, after it was surgically removed. The study is testing a method called focal ultrahypofractionated salvage radiotherapy, which delivers targeted radiation in just five sessions, combined with a short course of hormone therapy for six months. The goal is to see how effective and safe this treatment is, using advanced imaging techniques to pinpoint the exact location of the cancer recurrence.

To be eligible for this trial, participants must be adult men aged 18 and older who have been treated for prostate cancer with surgery at least six months prior and have evidence of cancer returning in the prostate bed, confirmed by specific imaging tests. Importantly, candidates should not have received hormone therapy before and must have certain levels of testosterone. If someone joins the study, they can expect to receive the new treatment regimen and regular follow-ups to monitor their progress. This trial is currently recruiting participants, and it aims to provide valuable insights into a potentially effective option for managing recurrent prostate cancer.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Written informed consent according to ICH/GCP (International Council for Harmonisation/Good Clinical Practice) regulations before registration and prior to any trial specific procedures
• • 2. Age ≥ 18 years at time of registration
• • 3. WHO performance status 0-1
• • 4. Lymph node negative adenocarcinoma of the prostate treated with radical prostatectomy (RP) at least 6 months before trial.Tumor stage pT2a-3b, R0-1, pN0 or cN0. according to the Union for International Cancer Control (UICC) TNM 2009.
• • 5. Evidence of measurable local recurrence at the prostate bed detected by PSMA PET/CT and mpMRI within the last 3 months. In case of unclear local recurrence, a biopsy confirmation is recommended.
• • 6. Patient must have non-metastatic (N0, M0) disease, as defined by a lack of nodal or distant metastases seen on PSMA PET/CT scan
• • 7. Patients must have non-castrate levels of serum testosterone (≥50 ng/dL).
• • 8. Patients must not have previously received hormonal therapy (LHRH agonists, antiandrogen, or both, or bilateral orchiectomy).
• • 9. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
• Exclusion Criteria:
• • 1. Persistent PSA (\> 0.4 ng/mL) 4 to 20 weeks after RP
• • 2. Previous hematologic or primary solid malignancy within 3 years prior registration with the exception of curatively treated localized non-melanoma skin cancer
• • 3. Usage of products known to affect PSA levels within 4 weeks prior to start of trial treatment phase including any form of androgen suppression agents and androgen deprivation therapy
• • 4. Bilateral hip prosthesis
• • 5. Severe or active co-morbidity likely to impact on the advisability of SRT
• • 6. Treatment with any experimental drug or participation within a clinical trial within 30 days prior to registration (exception: concurrent participation in the biobank studies is allowed)