Trial to Investigate the Benefit of Elective Para-Aortic Radiotherapy (PART) for pN1 Prostate Cancer

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Mar 8, 2017

Keywords

ClinConnect Summary

This clinical trial is looking to see if adding a specific type of radiation therapy, called elective para-aortic radiotherapy (PART), can help men with pN1 prostate cancer. pN1 means that the cancer has spread to nearby lymph nodes but not to other parts of the body. The trial compares the effects of this additional treatment to the usual treatment, which is whole pelvic radiotherapy (WPRT). Right now, the trial is actively recruiting male participants aged 65 to 74 who have not received any prior treatment for their prostate cancer and meet certain health criteria.

Participants in the trial will receive the new treatment and will be monitored to see how well it works. To be eligible, men need to have a confirmed diagnosis of prostate cancer, be in good overall health, and be willing to follow the trial's requirements. It's important to note that individuals with recurring cancer or other serious health issues may not be able to join. This study may provide valuable information on how to improve treatment for prostate cancer, so if you or someone you know is interested, it could be a great opportunity to contribute to cancer research.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Signed informed consent and willingness to comply with the treatment and follow-up
• • Diagnosis of histopathologically confirmed prostate cancer
• • No former treatment for prostate cancer
• • Presence of pN1 disease after ePLND (criteria defined in the protocol)
• • Age \> 18
• • Karnofsky Performance score \> 70
• • Ability to understand the informed consent (Helsinki Declaration)
• Exclusion Criteria:
• • Recurrent disease status
• • Presence of cM1a, cM1b or cM1c disease
• • Former radiotherapy making WPRT and/or PART impossible
• • Prior malignancy, not disease-free \> 5 years, except basocellular skin epithelioma
• • Severe or active comorbidity likely to impact on the feasibility of WPRT and/or PART
• • Disorder precluding understanding of trial information