Actively Recruiting
Enzalutamide and PDS01ADC in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy
Led by National Cancer Institute (NCI) · Updated on 2026-03-25
65
Participants Needed
1
Research Sites
297 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Prostate cancer may return after treatment in 30,000 to 50,000 people each year. There is no clear best way to treat these people. Better treatments are needed. Objective: To test a study drug (enzalutamide), both alone and combined with a second drug (PDS01ADC), in people with prostate cancer that returned after treatment. Eligibility: People aged 18 years and older with prostate cancer that returned after treatment. Design: Participants will be screened. They will have a physical exam, with blood tests. All their urine will be collected for 24 hours. They will have imaging scans of their chest, abdomen, pelvis, and bones. Their ability to perform everyday activities will be assessed. They may opt to give a stool sample. Participants will be treated in 4-week cycles. Enzalutamide is a pill taken by mouth once a day, every day. All participants will be given a supply of this drug to take at home. PDS01ADC is injected under the skin once a month, on the first day of each cycle. Half of the participants will receive both drugs. All participants will visit the clinic once a month. Each visit should last no more than 8 hours. Blood and urine tests will be repeated. All participants will receive the study treatment for 3 cycles. Some participants may need 3 more cycles of treatment with enzalutamide only. This re-treatment can be done only once. Participants will have a follow-up visit 1 month after they finish treatment. After that, they will have visits every 6 weeks for up to 5 years. Imaging scans and blood tests will be repeated. ...
CONDITIONS
Official Title
Enzalutamide and PDS01ADC in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants aged 18 years or older
- Histologic or cytological confirmation of prostate cancer, or rising PSA with PSMA+ disease and clinical history consistent with prostate cancer
- History of primary prostate cancer treatment (surgery or radiation)
- PSA doubling time less than 12 months before treatment
- Testosterone level greater than 100 ng/dL
- Evidence of prostate cancer on PSMA PET/CT scan
- ECOG performance status less than 2
- Agreement to use effective contraception during and for 3 months after treatment
- Adequate organ and marrow function defined by specific blood count and chemistry thresholds
- Undetectable HBV DNA if infected with hepatitis B, undetectable HCV RNA if infected with hepatitis C, undetectable HIV DNA if HIV-positive
- Ability to swallow tablets or capsules
- Willingness and ability to sign informed consent
You will not qualify if you...
- Presence of soft tissue disease on CT or MRI scans exceeding allowed criteria
- Evidence of bone lesions on Tc99 bone scan
- History of allergic reactions to similar compounds as study drugs or imaging agents
- Medical conditions requiring chronic systemic steroid or other immunosuppressive therapy (inhaled or topical steroids allowed)
- History of seizures within the last 10 years
- Use of strong CYP2C8 or CYP3A4 inhibitors or inducers within 5 half-lives before starting treatment
- Prior malignancy active within 3 years, except certain locally curable cancers
- Uncontrolled illnesses that could limit study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here