Actively Recruiting
Evaluating T-Cell Clonality After Radiation and Immunotherapy 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
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new drug called PDS01ADC to see if it can help the immune system fight localized intermediate and high risk prostate cancer. This cancer is often treated with radiation and androgen deprivation therapy (ADT), but up to 30% of patients experience cancer recurrence within five years. The study is a Phase II trial aiming to evaluate the safety of PDS01ADC combined with stereotactic body radiation therapy (SBRT) and to measure immune system activity by analyzing T-cell clonality. All participants will receive standard ADT and SBRT, which involves targeted high-dose radiation delivered in five sessions over about two weeks. Some participants will also receive PDS01ADC injections under the skin, starting about four weeks after radiation ends, with three doses given four weeks apart. The trial begins with a safety phase to find the tolerated dose of PDS01ADC, followed by a randomized phase comparing radiation alone to radiation plus PDS01ADC. Participants will undergo screening with physical exams, blood and urine tests, imaging scans including MRI and bone scans, and tumor biopsies. During the study, some tests will be repeated to monitor immune responses and safety. Follow-up visits will occur about one month after the last treatment or tests. The main outcomes include safety, tolerated doses, and immune activity measures over the study period, which lasts approximately seven months.
CONDITIONS
Brief 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: Gleason 7 disease, PSA less than 10
- High risk: Gleason 8-10, PSA greater than 10, or extracapsular extension
- Require stereotactic body radiation therapy (SBRT) to the prostate and androgen deprivation therapy (ADT)
- 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 as defined by specific blood count and chemistry criteria
- Testosterone level greater than 100 ng/dL
- Agree to use adequate contraception during and 6 months after treatment
- Prostate cancer accessible for biopsy
- Willing and able to provide informed consent
You will not qualify if you...
- Evidence of distant metastatic disease or positive lymph nodes outside the pelvis
- Prior prostatectomy, focal therapy, or radiation to the prostate
- Started ADT, SBRT, or pelvic nodal radiation before enrollment
- Live vaccine therapy within 30 days before treatment (except approved flu and COVID vaccines)
- Contraindications to MRI or SBRT such as rectal wall invasion or inflammatory bowel disease
- Medical conditions preventing ADT or posing high risk for study drug treatment
- Active immune deficiencies, autoimmune diseases, or chronic immunosuppressive therapy impacting immune response
- Use of systemic corticosteroids over 10 mg prednisone daily (with some exceptions)
- HIV infection
- Active Hepatitis B or C infection
- Significant infections including tuberculosis
- History of allergic reactions to compounds similar to PDS01ADC
- Prior malignancy active within 3 years except certain low-risk cancers or apparently cured skin and bladder cancers
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - SBRT over 2 to 3 weeks; PDS01ADC injections every 4 weeks for 3 doses
Participants receive stereotactic body radiation therapy (SBRT) to the prostate over approximately 2-3 weeks in 5 fractions delivered every other day. Those in the immunotherapy group receive up to 3 subcutaneous injections of PDS01ADC every 4 weeks at the dose determined during the safety lead-in. All participants receive androgen deprivation therapy as part of standard care.
5 radiation visits over 2 to 3 weeks; up to 3 subcutaneous injection visits every 4 weeks
Duration - Up to 4 weeks after end of treatment
Participants are monitored for safety and immunologic activity, including T-cell clonality and peripheral immune response, through assessments up to 4 weeks after the end of treatment.
Approximately 1 to 2 visits during follow-up
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
M
Melissa L Abel, M.D.
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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