Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer

Launched by REGINA ELENA CANCER INSTITUTE · Sep 23, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for men with unfavorable intermediate-risk or high-risk prostate cancer. Researchers want to see if combining a type of radiation therapy called SBRT (Stereotactic Body Radiation Therapy) with a medication called sTad can improve outcomes for patients. The trial is currently recruiting participants between the ages of 65 and 74 who have been diagnosed with prostate adenocarcinoma but have not had previous surgery or radiation treatment for their cancer.

To be eligible for the trial, participants must have a specific type of prostate cancer that hasn't spread (N0M0) and be in good enough health to participate, as indicated by their performance status. Those who join the trial can expect to receive either the SBRT treatment alone or the combination with sTad, with the goal of finding the most effective approach. It's important to note that participants will need to undergo certain tests, like an MRI, and have specific markers placed in their bodies to help track the treatment's effects. This trial aims to find better treatment options for men facing this challenging diagnosis.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Histologically proven prostate adenocarcinoma
• • IR or HR in the NCCN definition
• • N0M0 at staging with choline or (preferably) PSMA PET-CT;
• • ECOG performance status between 0 and 2;
• Exclusion Criteria:
• • Previous local treatment of the prostate with surgery (radical prostatectomy or cryotherapy)
• • Previous radiotherapy to the pelvis
• • Previous chemotherapy for malignancy in past 5 years
• • Impossibility to implant fiducials for tracking purposes
• • Impossibility to undergo MRI of the prostate
• • Contraindication to short term AD
• • Prostate volume \>90cc