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NCT06798558 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Lu-177-PSMA-617 in Patients With High Risk Localized Prostate Cancer Undergoing Radical Prostatectomy
A Phase 2 study of Prostate Adenocarcinoma, sponsored by Hackensack Meridian Health.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
- 3
- Study locations
NCT06798558: Recruiting Phase 2 study of Prostate Adenocarcinoma, sponsored by Hackensack Meridian Health.
NCT06798558 is a Phase 2 study of Prostate Adenocarcinoma that is actively recruiting participants, run by Hackensack Meridian Health. The registered enrollment target is 54 participants, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (75% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06798558, a Phase 2 study of Prostate Adenocarcinoma, is actively recruiting participants, sponsored by Hackensack Meridian Health.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
- 3
- Study locations
Study Summary
Male adults with a confirmed diagnosis of prostate adenocarcinoma who meet criteria for localized high risk prostate cancer according to the NCCN guidelines and who are eligible for prostatectomy will be invited to participate. Criteria for high-risk prostate cancer include patients with preoperative prostate biopsy score of Gleason 8 (GS8) (Grade group 4 \[GG4\]) or higher. Patients also need to have a positive PSMA scan on 68-Ga-PSMA-11 PET/CT scan.
Primary Outcome
Staging of prostate cancer is based on the correlation to Gleason Grade Group (GG) according to the American Joint Committee on Cancer (AJCC; 8TH edition, 2017) staging system for prostate cancer (see Appendix A). Prostate cancer downstaging is defined as the post-treatment stage less than the pre-treatment stage. Different downstaging thresholds will be applied including: * Complete downstaging (CD) is defined as no visible tumor in surgical sample; * Good response (GR) is defined as downstagi
Conditions Studied
Interventions
- DRUG Lu-17-PSMA-617
Study Locations (3)
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center - Washington D.C.
New Jersey
- John Theurer Cancer Center at Hackensack University Medical Center - Hackensack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2025-03-05 |
| Est. Completion | 2029-03 |
| Phase | Phase 2 |
What NCT06798558 shows while recruiting
NCT06798558 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 1 intervention - of which Lu-17-PSMA-617 is the first listed.
NCT06798558 reports a single indexed study location in District of Columbia, New Jersey.
Frequently Asked Questions
What is clinical trial NCT06798558 about?
NCT06798558 is a clinical study titled "Neoadjuvant Lu-177-PSMA-617 in Patients With High Risk Localized Prostate Cancer Undergoing Radical Prostatectomy". Male adults with a confirmed diagnosis of prostate adenocarcinoma who meet criteria for localized high risk prostate cancer according to the NCCN guidelines and who are eligible for prostatectomy will be invited to participate. Criteria for high-risk prostate cancer include patients with preoperativ...
What is the current status of trial NCT06798558?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2025-03-05. Estimated completion is 2029-03.
What conditions does trial NCT06798558 study?
This clinical trial studies the following conditions: Prostate Adenocarcinoma.
What interventions are being tested in trial NCT06798558?
The interventions under investigation include: Lu-17-PSMA-617 (DRUG).
Who is sponsoring clinical trial NCT06798558?
This trial is sponsored by Hackensack Meridian Health, which has 90 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06798558 being conducted?
This trial has 3 study locations across District of Columbia, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Adenocarcinoma
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 NCT06798558's enrollment target sits among peer trials
54 61st of 99 higher than 39 of 99 other Prostate Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Adenocarcinoma 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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