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NCT04748042 · ClinicalTrials.gov registry record · Phase 2
Focal Radiation With Pulsed Systemic Therapy of Abiraterone, Androgen Deprivation Therapy (ADT), Lynparza Towards Castration Sensitive Oligometastatic Prostate Cancer (FAALCON)
A Phase 2 study of Prostate Cancer and Oligometastatic Disease, sponsored by University of Michigan Rogel Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT04748042: Active Phase 2 study of Prostate Cancer and Oligometastatic Disease, sponsored by University of Michigan Rogel Cancer Center.
NCT04748042 is a Phase 2 study of Prostate Cancer and Oligometastatic Disease that is active but no longer recruiting, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 21 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04748042, a Phase 2 study of Prostate Cancer and Oligometastatic Disease, is active but no longer recruiting, sponsored by University of Michigan Rogel Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to assess the safety and effectiveness of radiation therapy with hormone therapy (ADT) and chemotherapy as an investigational study treatment for prostate cancer. This is a phase 2 study to deliver focal radiation with pulsed systemic therapy of Abiraterone, ADT and Lynparza (olaparib) in men with castration sensitive oligometastatic prostate cancer.
Primary Outcome
Treatment failure is defined as one of the following: * New or progressive metastases on Computed Tomogrophy (CT)/Magnetic Resonance Imaging (MRI) per Response Evaluation Criteria In Solid Tumors (RECIST) * New lesion(s) on bone scan without alternate explanations (e.g. trauma, arthritis) in distribution consistent with prostate cancer metastases, by provider assessment * Clinical progression by provider assessment * Prostate Specific Antigen (PSA) doubling time under 6 months with an absolute
Conditions Studied
Interventions
- DRUG Olaparib
- DRUG Prednisone
- DRUG Abiraterone
- RADIATION External Beam Radiotherapy
- BIOLOGICAL Androgen Deprivation Therapy (ADT)
Study Locations (1)
Michigan
- University of Michigan Rogel Cancer Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2021-05-28 |
| Est. Completion | 2026-05 |
| Phase | Phase 2 |
What the registry record for NCT04748042 still lists
NCT04748042 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 5 interventions - of which Olaparib is the first listed.
NCT04748042 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT04748042 about?
NCT04748042 is a clinical study titled "Focal Radiation With Pulsed Systemic Therapy of Abiraterone, Androgen Deprivation Therapy (ADT), Lynparza Towards Castration Sensitive Oligometastatic Prostate Cancer (FAALCON)". The purpose of this study is to assess the safety and effectiveness of radiation therapy with hormone therapy (ADT) and chemotherapy as an investigational study treatment for prostate cancer. This is a phase 2 study to deliver focal radiation with pulsed systemic therapy of Abiraterone, ADT and Lynp...
What is the current status of trial NCT04748042?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2021-05-28. Estimated completion is 2026-05.
What conditions does trial NCT04748042 study?
This clinical trial studies the following conditions: Prostate Cancer, Oligometastatic Disease, Castrate Sensitive Prostate Cancer.
What interventions are being tested in trial NCT04748042?
The interventions under investigation include: Olaparib (DRUG), Prednisone (DRUG), Abiraterone (DRUG), External Beam Radiotherapy (RADIATION), Androgen Deprivation Therapy (ADT) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04748042?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04748042 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT04748042's enrollment target sits among peer trials
21 646th of 735 higher than 84 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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