High-Risk prostatE Cancer radiatiOn Versus surgERy

Launched by COMPREHENSIVE CANCER CENTRE THE NETHERLANDS · Jun 27, 2023

Keywords

ClinConnect Summary

This clinical trial is looking into two different treatments for men with high-risk prostate cancer that has not spread to other parts of the body. The study compares robot-assisted surgery, which removes the prostate, with a type of radiation treatment combined with hormone therapy that helps to control cancer growth. Researchers want to find out which treatment leads to better quality of life, fewer complications, and longer survival without the cancer coming back or spreading.

To be eligible for this trial, participants must be men aged 18 to 80 who have been diagnosed with a specific type of prostate cancer called adenocarcinoma. They should have certain characteristics, such as a specific stage of cancer or a high level of a substance called PSA in their blood. Participants will be recruited from the Netherlands and need to be able to read and understand Dutch. Those who join the study can expect to receive one of the two treatments and be monitored for their health outcomes over time. It's important to note that certain types of prostate cancer or previous treatments may exclude individuals from participating.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Histologically confirmed de novo non-metastatic high-risk prostate cancer.
• • cT3a-bN0M0, according to the 8th edition of the Tumour, Node, Metastasis (TNM) classification, with the exception that clinical T-stage will be based on digital rectal examination and magnetic resonance imaging (the highest stage will be used) and/or
• • International Society of Urological Pathology (ISUP) grade ≥4 and/or
• • Prostate-Specific Antigen (PSA) value at diagnosis greater than 20 ng/mL
• • Fit for treatment with either RARP or EBRT and ADT (WHO performance status 0-1)
• • Living in the Netherlands
• • Able to read and understand the Dutch language
• Exclusion Criteria:
• • Histological types other than adenocarcinoma
• • Diagnosis and/or treatment in a hospital abroad
• • Treatment with Androgen Receptor Targeted Agents (ARTA) as part of the initial treatment plan