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18F-PSMA for Prostate Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Prostate Disease+6 More18F-PSMA - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial will use two new imaging technologies to see if they can detect prostate cancers that standard MRI couldn't.

Eligible Conditions
  • Prostate Disease
  • Tumors
  • Urogenital Neoplasms
  • Male Genital Diseases
  • Prostate Cancer
  • Male Genital Neoplasms

Treatment Effectiveness

Effectiveness Progress

1 of 3

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[18F]FLOR (FC303) Injection
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Study Objectives

3 Primary · 4 Secondary · Reporting Duration: 6 months following standard HIFU therapy

Month 6
Negative biopsy rate
Rate of high grade cancer
Secondary Endpoint (HIFU)
Secondary Endpoint (Prostatectomy)
Month 6
Exploratory Endpoint
Month 6
Prostate
Primary Endpoint (HIFU)
Week 3
Primary Endpoint (Prostatectomy)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Recombinant Interleukin-7
1
[18F]FLOR (FC303) Injection
1
Cytokine-Induced Memory-Like Natural Killer (CIML-NK) Cells

Trial Design

3 Treatment Groups

18F-PSMA
1 of 3
ARM 2 (RP) - 18F-PSMA
1 of 3
ARM 1 (HIFU) - 18F-PSMA
1 of 3

Experimental Treatment

61 Total Participants · 3 Treatment Groups

Primary Treatment: 18F-PSMA · No Placebo Group · Phase 2

18F-PSMA
Drug
Experimental Group · 1 Intervention: 18F-PSMA · Intervention Types: Drug
ARM 2 (RP) - 18F-PSMA
Drug
Experimental Group · 1 Intervention: 18F-PSMA · Intervention Types: Drug
ARM 1 (HIFU) - 18F-PSMA
Drug
Experimental Group · 1 Intervention: 18F-PSMA · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Piflufolastat F 18
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months following standard hifu therapy

Who is running the clinical trial?

Alessandro D'AgnoloLead Sponsor
Progenics Pharmaceuticals, Inc.Industry Sponsor
30 Previous Clinical Trials
4,777 Total Patients Enrolled
Alessandro D'Agnolo, MDPrincipal Investigator - Cedars-Sinai Medical Center
Cedars-Sinai Medical Center

Eligibility Criteria

Age 18+ · Male Participants · 5 Total Inclusion Criteria

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References

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