Actively Recruiting
Phase II Trial of Enzalutamide and PDS01ADC in PET Positive Recurrent Prostate Cancer Without Testosterone Lowering Therapy
Led by National Cancer Institute (NCI) · Updated on 2026-06-02
65
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for prostate cancer that has returned after initial therapy. This trial focuses on testing enzalutamide alone and combined with a second drug called PDS01ADC in men with PET positive recurrent prostate cancer who have not received testosterone lowering therapy. The study explores whether adding PDS01ADC can extend the time that prostate-specific antigen (PSA) levels remain low compared to enzalutamide alone. Participants will be randomly assigned to receive either enzalutamide alone or enzalutamide plus PDS01ADC. Enzalutamide is taken daily by mouth, while PDS01ADC is given as a monthly injection under the skin at the start of each 28-day treatment cycle. All participants will receive treatment for three cycles, with some possibly receiving up to three additional cycles of enzalutamide only. Treatments are given in 4-week cycles over several months. During the study, participants will undergo physical exams, blood and urine tests, 24-hour urine collection, and imaging scans of the chest, abdomen, pelvis, and bones. They will be monitored monthly during treatment and then followed up for up to five years with regular visits and repeated assessments. Researchers will measure PSA suppression duration, immune responses, PET scan changes, and treatment safety throughout the study.
CONDITIONS
Brief 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
- Confirmed prostate cancer diagnosis by biopsy or tumor sample, or rising PSA with PSMA+ disease and 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
- Eastern Cooperative Oncology Group (ECOG) performance status less than 2
- Agreement to use effective contraception during and for 3 months after treatment
- Adequate organ and marrow function as defined by specific blood count and chemistry criteria
- Ability to swallow tablets and provide informed consent
You will not qualify if you...
- Presence of soft tissue disease on CT or MRI scans exceeding criteria
- Bone lesions detected on Tc99 bone scan
- History of allergic reactions to similar drugs or imaging agents
- Chronic systemic steroid or immunosuppressive therapy (except inhaled or topical steroids)
- History of seizures within the past 10 years
- Use of strong CYP2C8 or CYP3A4 inhibitors or inducers within 5 half-lives before treatment
- Active malignancy within 3 years except certain cured cancers
- Uncontrolled illnesses that would interfere with study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Each cycle lasts 28 days; total of 3 cycles
Participants receive 3 cycles of treatment with enzalutamide alone or enzalutamide combined with PDS01ADC.
3 visits (in-person, one per cycle)
Duration - Up to the point of PSA recovery to baseline or longer
Participants are monitored after the initial treatment cycles to track PSA levels and disease status.
Visits scheduled based on monitoring needs
Duration - 3 cycles of 28 days each
Participants who experience PSA recovery to baseline receive a second course of 3 cycles of enzalutamide treatment only.
3 visits (in-person, one per cycle)
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
2
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