Pelvic Nodes Ultra-Hypo vs Conventionally Fractionated IMRT With HDR Boost in Prostate Cancer.

Launched by CHU DE QUEBEC-UNIVERSITE LAVAL · Apr 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different types of radiation therapy for men with prostate cancer that has a risk of spreading to the pelvic lymph nodes. One type, called ultra-hypofractionated radiation therapy (UHF), delivers a higher dose (5 Gy) in fewer sessions, while the other type uses a more traditional approach with smaller doses (1.8-2.15 Gy) spread over more sessions. Both methods will include a special boost of radiation directly to the prostate and possibly the nearby seminal vesicles, along with hormone therapy. The goal is to see if the UHF treatment is just as effective and well-tolerated as the standard treatment.

Men aged 65 to 74 who have been diagnosed with prostate adenocarcinoma and are at risk of lymph node involvement might be eligible for this trial. To participate, they need to be able to give informed consent and cannot have had previous pelvic radiation or certain other health conditions. Participants can expect to have their treatment monitored closely for any side effects and to see how well the cancer is controlled. This study is currently recruiting participants, and it aims to ensure that the new treatment option is safe and effective for those who qualify.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Histopathologically confirmed adenocarcinoma of the prostate.
• • All clinical stages with lymph node involvement risk needing pelvis RT.
• • Stage Mx or M0.
• • Unfavorable Intermediate, high or very high-risk disease according to NCCN guidelines.
• • Having the ability to give free and informed consent.
• Exclusion Criteria:
• • Clinical stage M1.
• • IPSS Score \> 20 with alpha-blocking medication.
• • Prior pelvic radiotherapy,
• • History of active collagenosis (Lupus, Scleroderma, Dermatomyositis).
• • Past history of Inflammatory Bowell Disease.
• • Bilateral hip prosthesis.