Single-dose radiotherapy for certain prostate cancers

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men with prostate cancer of intermediate or high risk that has not spread. They would receive a single high dose of radiotherapy, with an extra dose to the tumor seen on MRI.

Age

18 Years to 90 Years

Sex

Men only

Disease stage

Proven prostate adenocarcinoma, intermediate or high risk (NCCN definition), with no spread to lymph nodes or distant sites (N0M0).

Earlier treatment

No prior surgery or cryotherapy of the prostate, and no prior radiotherapy to the pelvis.

Main reasons for not taking part

• Disease at stage T3b or higher (8th AJCC classification)
• PSA above 20 ng/ml at any time
• Another invasive cancer in the past 5 years
• Active Crohn's disease or ulcerative colitis
• Life expectancy of 5 years or less, or ECOG status above 2

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 90 years old?YesNo

What the trial wants to find out

Published clinical evidence confirms that a single dose of 24 Gy provides unprecedented long-term local control in primary and metastatic prostate cancer with safe toxicity profiles, provided that exposure of surrounding healthy tissues is critically assessed with fulfillment of strict constraints and dose distribution is accomplished using image guidance and tracking tools. In the present trial, intermediate unfavorable and selected high-risk organ-confined prostate cancer patients will undergo Single Dose Radiation Therapy (SDRT) With Focal Boost to the MRI-defined Macroscopic Tumor Volume by means of image-guided volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) and state-of-the-art treatment-planning and quality assurance procedures. Androgen Deprivation Therapy (ADT) type and duration has been set as per standard of care, in accordance with current recommendations and guidelines.