68Ga-PSMA-11 PET for the Diagnosis of Metastatic Castration Resistant Prostate Cancer
Active, enrolledPhase 2Results postedLast updated 16 October 2024
What this trial tests
Phase 2 trial testing 68Ga-PSMA-11 in Castration-Resistant Prostate Carcinoma in 15 participants. Participants enrolled and being followed up; not accepting new ones.
18 and older, male only, with Castration-Resistant Prostate Carcinoma or Metastatic Prostate Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Who Progressed by Prostate-specific Antigen (PSA) Response GroupPrimary· Baseline, and up to 16 weeks after initiation of therapy
The percent of participants who fall into the PSA50 responders vs. non-responders based on PSMA treatment response criteria (PPP) for progression status will be reported. PPP uses 3 different criteria to determine response: 1) Appearance of 2 or more new PSMA positive distant lesions, 2) Appearance of 1 new PSMA positive lesion plus consistent clinical and/or laboratory data and recommended confirmation by biopsy or correlative imaging within 3 months of PSMA PET, and 3) Increase in size or PSMA uptake of 1 or more existing lesions by 30% plus consistent clinical and/or laboratory data and/or
PSA Responders who progressed
Group
Value
95% CI
Experimental (68Ga-PSMA-11 PET)
11.1
PSA Non-Responders who progressed
Group
Value
95% CI
Experimental (68Ga-PSMA-11 PET)
83.3
Sponsor's own description
This phase II trial studies the use of 68Ga-PSMA-11 positron emission tomography (PET) in diagnosing patients with prostate cancer that continues to grow despite the surgical removal of the testes or medical intervention to block androgen production (castration resistant), and has spread to other places in the body (metastatic). 68Ga- PSMA-11 is a new imaging agent that may help get more detailed pictures of the tumor. This trial aims to see whether using 68Ga-PSMA-11 PET scans may help doctors learn more about where disease is located in the body.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Sponsor: as reported to ClinicalTrials.gov by Thomas Hope
Last refreshed: 16 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04716725.