Phase II Trial of PDS01ADC Immunotherapy Combined with Stereotactic Body Radiation and Androgen Deprivation Therapy for Localized Intermediate and High Risk Prostate Cancer

What this Trial Is About

Researchers are studying localized intermediate and high risk prostate cancer to evaluate the safety and immune effects of a new drug called PDS01ADC combined with radiation therapy and androgen deprivation therapy ADT. This phase II trial focuses on measuring T-cell clonality, an immune system activity indicator, after treatment with stereotactic body radiation therapy SBRT alone or combined with PDS01ADC. The study aims to find safe dose levels of PDS01ADC and understand its impact on the immune response in prostate cancer patients. Participants will all receive SBRT to the prostate, delivered in five radiation sessions over 10 business days, plus ADT as standard care. Some participants will also receive PDS01ADC as a subcutaneous injection starting four weeks after finishing radiation. The drug will be given in three doses spaced four weeks apart, with dose levels adjusted during an initial safety lead-in phase. Participants not receiving PDS01ADC will still undergo regular testing while receiving SBRT and ADT. During the 7-month study, participants will be screened with medical history review, physical exam, blood and urine tests, imaging scans including bone scans and specialized MRI, and tumor biopsies. Testing to assess immune activity will be repeated at various points during treatment. Follow-up visits occur about one month after the last treatment or tests. Researchers will monitor safety, immune responses, and T-cell activity to understand how PDS01ADC works with radiation and ADT in prostate cancer treatment.

A Phase II Study Evaluating T-Cell Clonality After Stereotactic Body Radiation Therapy Alone and in Combination With the Immunocytokine PDS01ADC in Localized High and Intermediate Risk Prostate Cancer Treated With Androgen Deprivation Therapy