New drug aims to supercharge immune system against prostate cancer
NCT ID NCT05361798
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 10 times
Summary
This phase II trial tests whether adding an experimental drug called PDS01ADC to standard radiation and hormone therapy can help the immune system fight prostate cancer. About 65 men with high- or intermediate-risk prostate cancer that hasn't spread will take part. Some will get the drug after radiation, while others will receive only standard care, and researchers will compare immune responses.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PDS01ADC (an immunocytokine drug given as a shot under the skin)
- What this could lead to
- If it works, this could lead to a new combination treatment that helps the immune system better fight prostate cancer and reduces the chance of the cancer coming back.
- What could go wrong
- This is an early phase II trial with only 65 people, so results may not apply to everyone. The drug may cause side effects or fail to improve outcomes compared to standard therapy alone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 65 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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 barrier method of birth control; abstinence) after study entry and for 6 months after completion of radiation treatment or immunotherapy (if taken, whatever is last) * Participants must have prostate cancer accessible for biopsy * Ability of participant to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: * Evidence of distant metastatic disease (including clinically or pathologically positive lymph nodes or metastatic disease outside of the pelvis). * Previous prostatectomy, focal therapy, or radiation to the prostate. Note: Previous finasteride, dutasteride, bicalutamide are allowed at PI discretion. * Initiation of ADT or SBRT or pelvic nodal radiation irradiation prior to trial enrollment (no time limit). * Live vaccine therapies for the prevention of infectious disease within 30 days prior to treatment administration. Seasonal flu vaccines that do not contain a live virus are permitted. Locally approved COVID vaccines are permitted. * Contraindication to mpMRI including allergy or sensitivity to contrast agents (which cannot be alleviated by premedication) * Contraindications for SBRT such as: rectal wall invasion, history of inflammatory bowel disease, prior radiation in the treatment field that would exceed tissue tolerance. * Medical comorbidities that preclude the administration of androgen deprivation therapy or uncontrolled chronic or acute intercurrent illness /social situations or other illnesses considered by the Investigator as high risk for investigational drug treatment * Participants with active immune deficiencies, chronic inflammatory conditions, active autoimmune diseases, or participants on chronic immunosuppressive therapy for whom the primary endpoint of immune response could be impacted. * Participants requiring requiring systemic corticosteroids (\>10 mg daily prednisone equivalent) or immunosuppressive medications except inhaled steroids and adrenal replacement steroid doses up to 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Participants with a history of autoimmunity that has not required systemic immunosuppressive therapy or dose not threaten vital organ function including CN, heart, lungs, kidneys, skin and GI track will be allowed * Participants with HIV * Active Hepatitis B or Hepatitis C infection * Significant acute or chronic infections including tuberculosis (history of exposure or history of positive tuberculosis test; plus, presence of clinical symptoms, physical or radiographic findings) * History of allergic reactions attributed to compounds of similar chemical or biologic composition to PDS01ADC. * Participants with prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast or low risk Gleason 6 prostate cancer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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