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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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....
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzona diagnoza raka prostaty (biopsja lub raport patologa)
- •Rak prostaty rozprzestrzenił się na inne części ciała (widoczny na badaniach)
- •Dla pacjentów na wczesnym etapie choroby: rozpoczęcie leczenia hormonalnego nie więcej niż 134 dni temu
- •Dla pacjentów na zaawansowanym etapie: poprzednie leczenie nowoczesnymi lekami przeciw hormonom
- •Wiek 18 lat i więcej
- •Problemy z wcześniejszym leczeniem muszą się zagoić (poza drobnymi pozostałościami)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 110 Years
- Last updated (source)
- August 17, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (1)
National Institutes of Health Clinical Center
Bethesda, United States
Trial contact
Amy R Hankin, P.A.-C
Melissa L Abel, M.D.
Contact information from ClinicalTrials.gov. Contact in English.
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Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/8/2026.
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