A Phase II Study Evaluating T-Cell Clonality After Stereotactic Body Radiation Therapy Alone and in Combination With the Immunocytokine PDS01ADC in Localized High and Intermediate Risk Prostate Cancer Treated With Androgen Deprivation 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 is often treated with radiation and ADT (ADT is androgen deprivation therapy). Up to 30% of these cancers recur within 5 years of treatment. Researchers want to see if a new drug (PDS01ADC) can help the immune system to fight prostate cancer. Objective: To find what doses of PDS01ADC are safe in people who are treated for prostate cancer. Also, to see what effects PDS01ADC has on the immune system. Eligibility: People aged 18 and older with high- and intermediate-risk prostate cancer. Their cancer must not have spread to other parts of the body. Design: The study will last 7 months. Participants will be screened. They will share their medical history. They will also have: \<TAB\>A physical exam \<TAB\>Routine blood and urine tests \<TAB\>Imaging scans of the chest, abdomen, and pelvis \<TAB\>A bone scan \<TAB\>A tumor biopsy \<TAB\>A specialized MRI. Participants will lie face down on the MRI scanner table. An antenna that receives a signal may be placed in the rectum. All participants will be treated with radiation therapy and ADT. Some participants will also receive PDS01ADC as an injection under the skin. This treatment will start 4 weeks after the radiation has ended. Participants will receive a total of 3 doses. The injections will be 4 weeks apart. Some screening tests will be repeated at each visit. Participants who do not receive PDS01ADC will also have screening tests during the treatment period. Participants will return for follow-up about 1 month after the last treatment or set of tests.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Mężczyźni w wieku 18 lat i starsi z rakiem prostaty, który nie rozprzestrzenił się na inne części ciała.
- •Rak prostaty musi być potwierdzony w badaniach i być w grupie pośredniego lub wysokiego ryzyka.
- •Pacjenci muszą być zakwalifikowani do leczenia radioterapią prostaty (SBRT) i terapią hormonalną (ADT).
- •Dostępność próbki tkanki guza (pobranej nie dawniej niż rok przed badaniem) do analizy.
- •Ogólny stan zdrowia pacjenta pozwalający na udział w badaniu (oceniany m.in. przez lekarza).
- •Sprawnie działające narządy i szpik kostny (potwierdzone badaniami krwi).
- •Mężczyźni muszą zgodzić się na stosowanie skutecznych metod antykoncepcji przez określony czas po zakończeniu leczenia.
✗ Disqualifies
- •Rak prostaty, który rozprzzenił się na inne narządy lub węzły chłonne (przerzuty).
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- June 29, 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.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.