A PHASE II PROSPECTIVE TRIAL UTILIZING SHORT COURSE ANDROGEN DEPRIVATION THERAPY IN CONJUNCTION WITH ULTRA-HYPOFRACTIONATED SBRT FOR HIGH RISK NCCN PROSTATE CANCER WITH LOWER RISK ARTERA SCORES

Brief description of study

This is a Phase 2 study for patients with high-risk prostate cancer who have Gleason scores of 8–10 or PSA levels between 20 and 40, but whose ARTERA scores show their cancer may be less aggressive. Patients will receive 6 months of hormone therapy called androgen deprivation therapy (ADT), starting about 3 months before radiation and continuing during and after treatment. The hormone therapy can be given as monthly shots of leuprolide or degarelix, or as a daily pill called relugolix.

Patients will also get high-dose radiation therapy to the prostate and nearby lymph nodes. This may include a brachytherapy boost, a CyberKnife boost, or SBRT using an MRI-guided machine (MRI-Linac). During treatment, doctors will carefully track the position of the prostate and adjust the radiation target as needed to make sure it hits the cancer while avoiding healthy tissue.

The main goal of the study is to see how many patients develop cancer that spreads to other parts of the body within 5 years. Previous studies showed that long-term ADT helped prevent cancer spread better than short-term ADT, especially for Gleason 8–10 patients. This study is testing whether patients with lower-risk ARTERA scores can still have similar results—around 90% of patients staying free of metastases at 5 years—even with only 6 months of hormone therapy, which would be much better than the 75% seen with short-term ADT in past studies.


Clinical Study Identifier: s26-00056
Principal Investigator: Michael J. Zelefsky.
Other Investigators: Caitlin Elizabeth Ordonez Ferri, Nima Aghdam, Andrew Laccetti, Andrew J Evans, Cathy M Jensen, Minas Platon Economides, Matthew R Witten, Wei Phin Tan, Mary K O'Keeffe, Victor Ricardo Adorno Febles, Thomas B. Daniels, Jonathan Haas, Stephanie M Erichsen, Aaron Edward Katz, William C Huang, Nicholas Colangelo, Justin Lebenthal, Peter B. Schiff, David R. Wise.


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