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NCT06216249 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT)
A Phase 2 study of Prostate Carcinoma and Stage IVB Prostate Cancer American Joint Committee on Cancer (AJCC) v8, sponsored by Jonsson Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT06216249 is a Phase 2 study of Prostate Carcinoma and Stage IVB Prostate Cancer American Joint Committee on Cancer (AJCC) v8 that is actively recruiting participants, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 90 participants, below the 1,500-participant average among 59 other Prostate Carcinoma trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06216249, a Phase 2 study of Prostate Carcinoma and Stage IVB Prostate Cancer American Joint Committee on Cancer (AJCC) v8, is actively recruiting participants, sponsored by Jonsson Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study Summary
In advanced metastatic castration resistant prostate cancer (mCRPC) progressing after chemotherapy and androgen receptor (AR)-targeted therapy 177Lu-PSMA-617 is an effective treatment. 177Lu-PSMA-617 RLT is administered with a fixed schedule: 6 treatment cycles, administered every 6 weeks. However, the optimum number of cycles of 177Lu-PSMA in patients who show good response remains unknown. Some patients may benefit from more than 6 cycles of therapy. Additionally, some patients experience a complete or almost complete response before the last cycle. It is unclear whether these patients benefit from the subsequent remaining treatment cycle(s). A treatment holiday period would spare these patients some exposure to the therapy agent and avoid potentially unnecessary toxicity when treatment efficacy is already maximal and additional treatment effect cannot be expected. This randomized phase 2 study compares a group of patients treated with LuPSMA on a flexible and extended dosing schedule including "treatment holiday" periods (investigational arm, up to 12 cycles, as described below) to a control group treated with a fixed dosing schedule of 6 treatments cycles maximum administered every 6 weeks. The flexible dosing schedule in the investigational arm will be based on single photon emission computed tomography (SPECT)/computed tomography (CT) response assessments obtained 24h after injection of LuPSMA therapy cycle. The response assessment during treatment holiday period will be based on positron emission tomography/computed tomography (PET/CT) every 12 weeks. Single-time point SPECT/CT dosimetry protocol at every cycle will be performed and will allow to determine the number of cycles that subjects may receive under the study without exceeding the kidney dose threshold.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- OTHER Gallium Ga 68 Gozetotide
- DRUG Lutetium Lu 177 Vipivotide Tetraxetan
- PROCEDURE PSMA PET Scan
Study Locations (1)
California
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2024-08-01 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06216249
The ClinicalTrials.gov registry entry for NCT06216249 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,500-participant average among 59 other Prostate Carcinoma trials with a reported enrollment target (94% lower). The listed sponsor is Jonsson Comprehensive Cancer Center, which has 321 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Prostate Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT06216249 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT06216249 about?
NCT06216249 is a clinical study titled "Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT)". In advanced metastatic castration resistant prostate cancer (mCRPC) progressing after chemotherapy and androgen receptor (AR)-targeted therapy 177Lu-PSMA-617 is an effective treatment. 177Lu-PSMA-617 RLT is administered with a fixed schedule: 6 treatment cycles, administered every 6 weeks. However, ...
What is the current status of trial NCT06216249?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2024-08-01. Estimated completion is 2028-12-31.
What conditions does trial NCT06216249 study?
This clinical trial studies the following conditions: Prostate Carcinoma, Stage IVB Prostate Cancer American Joint Committee on Cancer (AJCC) v8.
What interventions are being tested in trial NCT06216249?
The interventions under investigation include: Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Gallium Ga 68 Gozetotide (OTHER), Lutetium Lu 177 Vipivotide Tetraxetan (DRUG), PSMA PET Scan (PROCEDURE).
Who is sponsoring clinical trial NCT06216249?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06216249 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.