NCT04186845

Imaging Study to Investigate Safety and Diagnostic Performance of rhPSMA 7.3 (18F) PET Ligand in Suspected Prostate Cancer Recurrence (SPOTLIGHT)

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

COMPLETED

NCT ID:

NCT04186845

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

A Prospective, Phase 3, Multi Center, Single-arm, Imaging Study Investigating the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) PET Ligand in Men With Suspected Prostate Cancer Recurrence Based on Elevated PSA Following Prior Therapy.

Summary

A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of rhPSMA 7.3 (18F) Positron Emission Tomography (PET) ligand in men with suspected prostate cancer recurrence based on elevated Prostate-specific antigen (PSA) following prior therapy.

Eligibility

Inclusion Criteria:

1. Patient is male and aged \>18 years old.
2. History of localized adenocarcinoma of the prostate with prior curative intent treatment.
3. An elevated PSA, clinically suspicious for biochemically recurrent disease:

* Following Radical Prostatectomy: PSA \>0.2 ng/mL
* Following Radiotherapy: nadir +2 ng/mL.
4. Potentially eligible for salvage therapy with curative intent.

Exclusion Criteria:

1. Patients who are planned to have an x-ray contrast agent or other PET radiotracer \<24 hours prior to the PET scan.
2. Patients currently receiving Androgen Deprivation Therapy (ADT).

Disease(s) and\or Condition(s)

Prostate Cancer

Primary Purpose

DIAGNOSTIC

Intervention/Treatment

- Type: DRUG
- Name: rhPSMA-7.3 (18F) Injection
- Description: Radioligand for PET CT scanning
- Arm Group Labels: Patients

Sponsor

Blue Earth Diagnostics