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 2026-05-27
86
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of combining docetaxel with PDS01ADC for men with metastatic castration sensitive prostate cancer (mCSPC) and metastatic castration resistant prostate cancer (mCRPC). Men with these types of prostate cancer, which have spread to other parts of the body, are being studied to see if this combination can delay disease progression. The study is a Phase I/II trial focused on patients receiving standard treatments alongside the investigational drug PDS01ADC. Participants will receive treatments in cycles lasting 21 days. Docetaxel will be given through an intravenous infusion every three weeks, with PDS01ADC administered as a subcutaneous injection at escalating doses initially, then at a recommended phase 2 dose. Men with mCSPC will receive up to six treatment cycles, including abiraterone and optional prednisone, while men with mCRPC will continue treatment until side effects become intolerable or the disease worsens. Androgen deprivation therapy (ADT) will be maintained or given according to standard care. During the study, participants will undergo thorough assessments including medical history, physical exams, blood and urine tests, heart evaluations, and imaging scans of the chest, abdomen, pelvis, and bones. Some tests may be repeated during treatment, and tumor biopsies may be performed. Researchers will monitor safety, tolerability, prostate-specific antigen (PSA) levels, radiographic responses, and progression-free survival. Follow-up visits will occur 30 days after treatment ends, with additional visits every three months for mCSPC patients. Total study participation may last up to four years for enrollment and follow-up.
CONDITIONS
Brief 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 age 18 years or older
- Histopathological confirmation of prostate cancer or pathologist's report consistent with diagnosis
- Must have metastatic disease confirmed by bone scan or measurable lesion per RECIST 1.1
- For mCSPC participants: within 134 days of starting androgen deprivation therapy (ADT)
- mCSPC participants in dose expansion must have high volume disease (visceral lesion or 4+ bone lesions with at least one beyond spine and pelvis)
- For mCRPC participants: previously treated with modern anti-androgens such as abiraterone or enzalutamide
- No progression while on docetaxel or within 3 months after completing docetaxel for mCSPC
- Toxicities from prior therapy must have resolved to grade 1 or less
- ECOG performance status 0-2
- Adequate organ and marrow function as defined by laboratory criteria
- Willingness to use medically accepted contraception during and after the study
- Ability to understand and sign informed consent
- Willingness to travel to NIH for follow-up visits
- Prior immune checkpoint therapy allowed at investigator discretion
You will not qualify if you...
- Positive for HIV or other immunodeficiency diseases
- Active autoimmune diseases requiring systemic immunosuppressive therapy
- Serious medical illnesses interfering with treatment
- Current use of medications altering PSA or interacting with study drugs
- Receipt of investigational agents within 28 days or antibody drug conjugates within 60 days
- Positive for Hepatitis B surface antigen or Hepatitis C antibody
- Uncontrolled hypertension (SBP >170 or DBP >105)
- Recent live vaccine within 30 days prior to first study dose
- Prior docetaxel treatment for mCRPC
- mCSPC participants who did not start abiraterone within 6 weeks of ADT or had prior docetaxel
- Progression within 3 months of completing docetaxel for mCSPC
- History of allergic reactions to similar compounds as PDS01ADC
- Another active malignancy requiring systemic treatment within 3 years (except certain skin and bladder cancers)
- Active brain metastases or epidural disease
- Peripheral neuropathy grade 2 or higher at baseline
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.
Duration - Up to 18 weeks for mCSPC or until progression for mCRPC
Participants receive combination treatment with docetaxel and PDS01ADC. For metastatic castration sensitive prostate cancer (mCSPC), participants also receive abiraterone and prednisone along with androgen deprivation therapy (ADT). Treatment cycles occur every 3 weeks, with mCSPC participants receiving up to 6 cycles and mCRPC participants continuing until disease progression or unacceptable toxicity.
Every 3 weeks visits corresponding to each treatment 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
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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