OncoMatch/Clinical Trials/NCT05361798
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
Is NCT05361798 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies PDS01ADC for cancer of prostate.
Treatment: PDS01ADC — 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.
Check if I qualifyExtracted eligibility criteria
Disease stage
Excluded: Stage DISTANT METASTATIC DISEASE, CLINICALLY OR PATHOLOGICALLY POSITIVE LYMPH NODES, METASTATIC DISEASE OUTSIDE OF THE PELVIS
Grade: Gleason 7 (intermediate risk)Gleason 8-10 (high risk) (Gleason)
Intermediate risk - Gleason 7 disease, PSA less than 10; High Risk - Gleason 8-10, PSA>10, Extracapsular Extension
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: prostatectomy
Previous prostatectomy
Cannot have received: focal therapy
Previous focal therapy
Cannot have received: radiation therapy to the prostate
Previous radiation to the prostate
Cannot have received: androgen deprivation therapy
Initiation of ADT ... prior to trial enrollment
Cannot have received: SBRT
Initiation of SBRT ... prior to trial enrollment
Cannot have received: pelvic nodal radiation irradiation
Initiation of ... pelvic nodal radiation irradiation prior to trial enrollment
Lab requirements
Blood counts
absolute neutrophil count >= 1,500/mcL, without CSF support; platelets >= 100,000/mcL; Hgb >= 10g/dL (pRBC transfusions are not allowed to achieve acceptable Hgb); PT/INR and aPTT <= 1.5 X institutional ULN
Kidney function
Creatine <= 1.5 X institutional ULN OR Creatinine clearance >= 50 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal by 24h urine
Liver function
AST(SGOT)/ALT(SGPT) <= 2.5 X institutional upper limit of normal; Total bilirubin <= 1.5 x upper limit of normal (ULN), or <= 3.0 in participants with Gilbert's syndrome; Serum albumin >= 2.8 g/dL
adequate organ and marrow function as defined below: absolute neutrophil count >= 1,500/mcL, without CSF support; platelets >= 100,000/mcL; AST(SGOT)/ALT(SGPT) <= 2.5 X institutional upper limit of normal; Hgb >= 10g/dL (pRBC transfusions are not allowed to achieve acceptable Hgb); Total bilirubin <= 1.5 x upper limit of normal (ULN), or <= 3.0 in participants with Gilbert's syndrome; Serum albumin >= 2.8 g/dL; Creatine <= 1.5 X institutional ULN OR Creatinine clearance >= 50 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal by 24h urine; PT/INR and aPTT <= 1.5 X institutional ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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