Daily Adaptive RadioTherapy in Postoperative HypofrActionated Salvage radiothERapy for Prostate Cancer Patients

Launched by IRCCS SACRO CUORE DON CALABRIA DI NEGRAR · May 23, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new approach to treating prostate cancer in men who have had surgery but are experiencing a rise in their prostate-specific antigen (PSA) levels, which may indicate a recurrence of cancer. The study is looking at how well a specific type of radiation therapy, called hypofractionated postoperative salvage radiotherapy, works when adjusted daily for each patient. Participants will receive a total of 59 Gy of radiation, split into 20 smaller doses, to see how they respond and to monitor any side effects from the treatment.

To be eligible for this trial, participants should be men aged 18 to 80 with a diagnosis of prostate cancer that has not spread outside the prostate (no distant metastases). They should have had surgery for prostate cancer and are now showing signs of biochemical recurrence, with PSA levels indicating the need for further treatment. Participants will be closely monitored throughout the study, and the results will be compared to previous studies to better understand the effectiveness and safety of this treatment approach. If you're considering joining the study, you'll need to provide your consent and agree to how your personal data will be handled.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Age ≤ 80 years;
• • Prostate cancer diagnosis, pT2-3 pN0, any resection margin (R0 or R1);
• • Indication to local salvage treatment defined as: early salvage radiotherapy after primary prostate surgery (radical prostatectomy) with PSA \<0.2 ng/ml or salvage radiotherapy after primary prostate surgery (radical prostatectomy) with PSA ≥0.2 ng/ml;
• • No distant metastases (M0) diagnosed with PSMA-PET-CT;
• • Informed consent to trial's participation and personal data treatment.
• Exclusion Criteria:
• • Age \<18 years old;
• • Adjuvant radiotherapy;
• • Previous radiation in the same anatomical site.