Actively Recruiting
A Phase I/II Study of PDS01ADC With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and PDS01ADC With Docetaxel in Castration Resistant Prostate Cancer
Led by National Cancer Institute (NCI) · Updated on 2026-04-08
86
Participants Needed
1
Research Sites
305 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Metastatic castration sensitive and castration resistant prostate cancer (mCSPC and mCRPC) are prostate cancers that have spread to other parts of the body. Use of the drug docetaxel with androgen deprivation therapy can improve survival for men with mCSPC. Researchers want to see if combining this treatment with other drugs can help delay the time it takes for mCSPC and mCRPC to get worse. Objective: To learn if giving docetaxel with PDS01ADC is safe and effective for men with prostate cancer. Eligibility: Men age 18 and older with mCSPC or mCRPC. Design: Participants will be screened with a medical history and physical exam. Their diagnosis will be confirmed. Their symptoms and how well they do their normal activities will be reviewed. They will have blood and urine tests. Their heart will be evaluated. They will have imaging scans of the chest, abdomen, and pelvis. They will have bone scans with intravenous (IV) injections of Tc99 to check for tumor spread in the bones. Some screening tests will be repeated during the study. Participants may have tumor biopsies. Participants will get treatment in cycles. Each cycle will last 21 days. They will get docetaxel through IV infusion. They will get PDS01ADC as an injection under the skin. Participants with mCSPC will have up to 6 cycles. Those with mCRPC will be treated until they cannot tolerate the side effects or their disease gets worse. Participants will have a follow-up visit 30 days after treatment ends. Those with mCSPC will then have follow-up visits at the clinic every 3 months.
CONDITIONS
Official Title
A Phase I/II Study of PDS01ADC With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and PDS01ADC With Docetaxel in Castration Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men aged 18 years or older
- Histopathological confirmation of prostate cancer or pathologist's report consistent with diagnosis
- Presence of metastatic disease confirmed by bone scan or measurable lesion
- For mCSPC participants: within 134 days of starting androgen deprivation therapy (ADT)
- For mCSPC dose expansion cohort: must have high volume disease (visceral lesion or 4+ bone lesions, with at least one beyond spine and pelvis)
- For mCRPC participants: require ADT unless previously had orchiectomy
- For mCRPC participants: previously treated with modern anti-androgens such as abiraterone, enzalutamide, apalutamide, or darolutamide
- No progression on docetaxel during or within 3 months after treatment for mCSPC
- Toxicities from prior therapies resolved to grade 1 or less
- ECOG performance status 0-2
- Adequate organ and marrow function as defined by specified blood counts and liver/kidney function
- Ability to understand and willing to sign informed consent and travel for follow-up visits
- Prior immune checkpoint therapy allowed at investigator discretion
You will not qualify if you...
- Immunocompromised status due to HIV, active autoimmune diseases requiring systemic immunosuppressive therapy, or other immunodeficiency diseases
- Serious medical illness interfering with treatment ability
- Current use of medications affecting PSA levels or interacting with study drugs
- Use of investigational agents within 28 or 60 days before study drug
- Positive for Hepatitis B surface antigen or Anti-Hepatitis C antibody
- Uncontrolled hypertension (blood pressure above 170/105 mmHg)
- Receipt of live vaccines within 30 days before study
- Previous docetaxel treatment for mCRPC
- For mCSPC participants: no abiraterone within 6 weeks of ADT start or any prior docetaxel
- Progression within 3 months after completing docetaxel for mCSPC
- History of allergic reactions to similar compounds to PDS01ADC
- Another active malignancy requiring systemic treatment within past 3 years, except certain skin or bladder cancers
- Active brain metastases or epidural disease
- Peripheral neuropathy grade 2 or higher at baseline
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
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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