Timing of Post-prostatectomy PSMA Imaging

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Aug 12, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the best timing for imaging tests after prostate cancer surgery to see if the cancer has returned. Specifically, it looks at men who have a low level of prostate-specific antigen (PSA) in their blood after surgery, which suggests early signs of cancer coming back. Participants will be randomly assigned to either receive early radiation treatment or to be closely monitored over time. Those in the monitoring group will have their PSA levels checked every three months and will only undergo imaging if their PSA rises to a certain level.

To be eligible for this trial, men must have been diagnosed with prostate cancer, have had surgery to remove their prostate, and have a PSA level that falls between 0.1 and 0.3 ng/mL. They also need to be able to provide informed consent, meaning they understand the study and agree to participate. If you join the trial, you will receive regular check-ups and either start treatment right away or be monitored for changes in your PSA levels. This trial is important because it aims to find out the most effective approach for managing early signs of cancer recurrence, helping future patients receive better care.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Histologically-proven prostate cancer
• • pT1-T4 pN0/Nx cM0
• • PSA at BCR \>0.1 - \<0.3 ng/mL post-radical prostatectomy
• • PSMA PET/CT negative at BCR post radical prostatectomy
• • Planned SRT to prostate bed +/- pelvic lymph nodes
• • ECOG 0 or 1
• • Age ≥ 18 years
• • Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.
• Exclusion Criteria:
• • Active or post prostatectomy androgen deprivation use
• • Previous pelvic radiotherapy
• • Other contraindications to radiotherapy