Actively Recruiting
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
Led by National Cancer Institute (NCI) · Updated on 2026-04-06
65
Participants Needed
1
Research Sites
181 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 years or older
- Histologically or cytologically confirmed localized intermediate or high risk prostate cancer
- Intermediate risk defined as Gleason 7 disease with PSA less than 10
- High risk defined as Gleason 8-10, PSA greater than 10, or extracapsular extension
- Requires treatment with SBRT to the prostate and androgen deprivation therapy
- Pre-treatment tissue available for biomarker analysis within 1 year before study therapy
- ECOG performance status less than 2
- Adequate organ and bone marrow function including specific blood counts and liver function
- Testosterone greater than 100 ng/dL
- Agreement to use contraception during study and for 6 months after treatment
- Prostate cancer accessible for biopsy
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Evidence of distant metastatic disease including positive lymph nodes outside the pelvis
- Previous prostatectomy, focal therapy, or radiation to the prostate
- Started androgen deprivation therapy, SBRT, or pelvic nodal radiation before enrollment
- Use of live vaccines within 30 days prior to treatment
- Contraindications to multiparametric MRI including allergy to contrast agents
- Contraindications for SBRT such as rectal wall invasion, inflammatory bowel disease, or prior radiation exceeding tissue tolerance
- Medical conditions preventing use of androgen deprivation therapy or considered high risk by investigator
- Active immune deficiencies, chronic inflammatory conditions, autoimmune diseases, or use of immunosuppressive therapy that impacts immune response
- Use of systemic corticosteroids above 10 mg prednisone equivalent daily
- HIV infection
- Active hepatitis B or C infection
- Significant acute or chronic infections including tuberculosis
- History of allergic reactions to compounds similar to PDS01ADC
- Prior malignancy active within 3 years except for certain locally curable cancers or low risk prostate cancer
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
A
Amy R Hankin, P.A.-C
CONTACT
M
Melissa L Abel, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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