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NCT06096870 · ClinicalTrials.gov registry record · Phase 2
Enzalutamide and PDS01ADC in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy
A Phase 2 study of Prostate Cancer and Recurrent Prostate Cancer, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT06096870: Recruiting Phase 2 study of Prostate Cancer and Recurrent Prostate Cancer, sponsored by National Cancer Institute (NCI).
NCT06096870 is a Phase 2 study of Prostate Cancer and Recurrent Prostate Cancer that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 65 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06096870, a Phase 2 study of Prostate Cancer and Recurrent Prostate Cancer, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study Summary
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. ...
Primary Outcome
Kaplan-Meier curves and a one-tailed log-rank test. The median time to loss of PSA control on each arm will be reported along with a 95% confidence interval; in addition, based on the result from the prior trial, the probability of PSA control at 224 days (approximately 7 months) will also be reported on both arms, along with 95% confidence intervals
Conditions Studied
Interventions
- DRUG Enzalutamide
- DRUG PDS01ADC
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2024-04-22 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 2 |
What NCT06096870 shows while recruiting
NCT06096870 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (89% lower).
The record links to 3 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Enzalutamide is the first listed.
NCT06096870 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06096870 about?
NCT06096870 is a clinical study titled "Enzalutamide and PDS01ADC in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy". 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 prosta...
What is the current status of trial NCT06096870?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2024-04-22. Estimated completion is 2029-12-31.
What conditions does trial NCT06096870 study?
This clinical trial studies the following conditions: Prostate Cancer, Recurrent Prostate Cancer, PET Positive.
What interventions are being tested in trial NCT06096870?
The interventions under investigation include: Enzalutamide (DRUG), PDS01ADC (DRUG).
Who is sponsoring clinical trial NCT06096870?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06096870 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06096870's enrollment target sits among peer trials
65 411th of 735 higher than 325 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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