Enzalutamide and PDS01ADC in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy
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: 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. ...
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18 lat lub więcej
- •Potwierdzony wcześniej rak prostaty (biopsja lub dokumentacja)
- •Rak powrócił po operacji lub radioterapii
- •Szybki wzrost poziomu PSA (podwojenie w ciągu poniżej 12 miesięcy)
- •Normalny poziom testosteronu (powyżej 100 ng/dL)
- •Widoczne ogniska nowotworu na badaniu PET/CT
- •Dobre ogólne samopoczucie (zdolność do codziennych czynności)
- •Prawidłowa funkcja nerek, wątroby i szpiku kostnego
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 120 Years
- Last updated (source)
- July 24, 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.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/17/2026.
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