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
Recruiting
Phase 2
Interventional Study
Cancer Of Prostate
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Male
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 65 (estimated)
- Sponsor
- National Cancer Institute (NCI) · NIH
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About This 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 PD…
Trial Locations
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Eligibility Criteria
* INCLUSION CRITERIA:
* Participants must have histologically or cytologically confirmed localized intermediate or high risk prostate cancer:
* Intermediate risk - Gleason 7 disease, PSA less than 10
* High Risk - Gleason 8-10, PSA\>10, Extracapsular Extension
* Participants must require treatm…
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