RecruitingPhase 2

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

United States65 participantsStarted 2023-06-12

Plain-language summary

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.

Who can participate

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: * Participants must have histologically or cytologically confirmed localized intermediate or high risk prostate cancer: * Intermediate risk - Gleason 7 disease, PSA less than 10 * High Risk - Gleason 8-10, PSA\>10, Extracapsular Extension * Participants must require treatment with SBRT to the prostate and ADT. * Pre-treatment tissue availability (collected \<= 1 year to initiation of study therapy) for biomarker analysis is mandatory for enrollment. If tissue is determined to be of insufficient/unsuitable quality/quantity, a pre-treatment biopsy prior to initiation of study therapy will be required. * Male age \>= 18 years old * ECOG performance status \< 2 * Participants must have 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 in participants with Gilbert s syndrome, a total bilirubin \<= 3.0 * 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 * Testosterone greater than 100 ng/dL. * Men must agree to use adequate contraception (hormonal or …

What they're measuring

To determine safety and tolerated doses of PDS01ADC and SBRT

Timeframe: four weeks after start of treatment

evaluate T-cell clonality as measures of immunologic activity

Timeframe: baseline through 4 weeks after end of treatment

Trial details

NCT IDNCT05361798

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2026-08-01

Contact for this trial

Amy R Hankin, P.A.-C

(240) 858-3149 amy.hankin@nih.gov