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NCT05361798 · ClinicalTrials.gov record · last posted 2026-08-11

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

StatusRecruiting
PhasePhase 2
Started2023-06-12
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from the ClinicalTrials.gov record
Background: Prostate cancer is often treated with radiation and ADT (ADT is androgen deprivation therapy). Up to 30% of these cancers recur within 5 years of treatment. Researchers want to see if a new drug (PDS01ADC) can help the immune system to fight prostate cancer. Objective: To find what doses of PDS01ADC are safe in people who are treated for prostate cancer. Also, to see what effects PDS01ADC has on the immune system. Eligibility: People aged 18 and older with high- and intermediate-risk prostate cancer. Their cancer must not have spread to other parts of the body. Design: The study will last 7 months. Participants will be screened. They will share their medical history. They will also have: \<TAB\>A physical exam \<TAB\>Routine blood and urine tests \<TAB\>Imaging scans of the chest, abdomen, and pelvis \<TAB\>A bone scan \<TAB\>A tumor biopsy \<TAB\>A specialized MRI. Participants will lie face down on the MRI scanner table. An antenna that receives a signal may be placed in the rectum. All participants will be treated with radiation therapy and ADT. Some participants will also receive PDS01ADC as an injection under the skin. This treatment will start 4 weeks after the radiation has ended. Participants will receive a total of 3 doses. The injections will be 4 weeks apart. Some screening tests will be repeated at each visit. Participants who do not receive PDS01ADC will also have screening tests during the treatment period. Participants will return for follow-up about 1 month after the last treatment or set of tests.

Protocol amendment history 3 changes detected by DataLookout

2026-08-12
critical
Primary completion pushed: 2026-08-01 → 2027-08-01
2026-08-12
minor
Completion pushed: 2026-12-01 → 2027-12-01
2026-03-31
critical
Primary endpoint(s) modified
WasTo determine safety and tolerated doses of M9241 and SBRT, evaluate T-cell clonality as measures of immunologic activity
NowTo determine safety and tolerated doses of PDS01ADC and SBRT, evaluate T-cell clonality as measures of immunologic activity
Trial Details
NCT Number NCT05361798
Lead Sponsor National Cancer Institute (NCI)
Conditions Cancer Of Prostate
Enrollment 65 participants
Start Date 2023-06-12
Primary Completion 2027-08-01 (estimated)
Study Completion 2027-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-11