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NCT05113537 · ClinicalTrials.gov registry record · Phase 1
Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer
A Phase 1 study of Metastatic Castration-Resistant Prostate Cancer and Stage IVB Prostate Cancer AJCC v8, sponsored by Vadim S Koshkin.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05113537 is a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer and Stage IVB Prostate Cancer AJCC v8 that is actively recruiting participants, run by Vadim S Koshkin. The registered enrollment target is 30 participants, below the 197-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05113537, a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer and Stage IVB Prostate Cancer AJCC v8, is actively recruiting participants, sponsored by Vadim S Koshkin.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial tests the safety, side effects, and best dose of abemaciclib and whether it works before 177Lu-PSMA-617 in treating patients with castration resistant prostate cancer that has spread to other places in the body (metastatic). Abemaciclib is in a class of medications called kinase inhibitors. It is highly selective inhibitors of cyclin-dependent kinase 4 and 6, which are proteins involved in cell differentiation and growth. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. Radioligand therapy uses a small molecule (in this case 177Lu-PSMA-617), which carries a radioactive component to destroys tumor cells. When 177Lu-PSMA-617 is injected into the body, it attaches to the prostate-specific membrane antigen (PSMA) receptor found on tumor cells. After 177Lu-PSMA-617 attaches to the PSMA receptor, its radiation component destroys the tumor cell. Giving abemaciclib before 177Lu-PSMA-617 may help 177Lu-PSMA-617 kill more tumor cells.
Conditions Studied
Interventions
- DRUG Abemaciclib
- DRUG Lutetium Lu 177-PSMA-617
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-07-08 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05113537
The ClinicalTrials.gov registry entry for NCT05113537 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 197-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (85% lower). The listed sponsor is Vadim S Koshkin, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Metastatic Castration-Resistant Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Abemaciclib is the first listed.
NCT05113537 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05113537 about?
NCT05113537 is a clinical study titled "Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer". This phase I/II trial tests the safety, side effects, and best dose of abemaciclib and whether it works before 177Lu-PSMA-617 in treating patients with castration resistant prostate cancer that has spread to other places in the body (metastatic). Abemaciclib is in a class of medications called kinas...
What is the current status of trial NCT05113537?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2022-07-08. Estimated completion is 2027-12-31.
What conditions does trial NCT05113537 study?
This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostate Cancer, Stage IVB Prostate Cancer AJCC v8, Castration-Resistant Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8.
What interventions are being tested in trial NCT05113537?
The interventions under investigation include: Abemaciclib (DRUG), Lutetium Lu 177-PSMA-617 (DRUG).
Who is sponsoring clinical trial NCT05113537?
This trial is sponsored by Vadim S Koshkin, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05113537 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Metastatic Castration-Resistant Prostate Cancer
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Stage IVB Prostate Cancer AJCC v8
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