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NCT04633252 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Cancer Of Prostate and Prostate Neoplasms, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 86
- Enrollment target
- 1
- Study location
NCT04633252: Recruiting Phase 1 study of Cancer Of Prostate and Prostate Neoplasms, sponsored by National Cancer Institute (NCI).
NCT04633252 is a Phase 1 study of Cancer Of Prostate and Prostate Neoplasms that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 86 participants, below the 1,927-participant average among 7 other Cancer Of Prostate trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04633252, a Phase 1 study of Cancer Of Prostate and Prostate Neoplasms, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 86 participants
- Enrollment target
- 1
- Study location
Study Summary
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 M9241 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.
Primary Outcome
For castration sensitive: Increase in the proportion of participants who have less than 0.2 ng/ml of PSA. For castration resistant: Increase in median progression free survival
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Prednisone
- DRUG ADT
- DRUG M7824
- DRUG M9241
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2021-02-23 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What NCT04633252 shows while recruiting
NCT04633252 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 1,927-participant average among 7 other Cancer Of Prostate trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Cancer Of Prostate appearing as the primary indexed condition, and to 5 interventions - of which Docetaxel is the first listed.
NCT04633252 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04633252 about?
NCT04633252 is a clinical study titled "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". 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 co...
What is the current status of trial NCT04633252?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 86 participants. The study started on 2021-02-23. Estimated completion is 2026-12-31.
What conditions does trial NCT04633252 study?
This clinical trial studies the following conditions: Cancer Of Prostate, Prostate Neoplasms.
What interventions are being tested in trial NCT04633252?
The interventions under investigation include: Docetaxel (DRUG), Prednisone (DRUG), ADT (DRUG), M7824 (DRUG), M9241 (DRUG).
Who is sponsoring clinical trial NCT04633252?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04633252 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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