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 newly diagnosed prostate cancer

Phase 3

Completed

• Conditions: Prostate cancer; 10027656

• Registration Number: NL-OMON55168
• Lead Sponsor: Blue Earth Diagnostics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2022-05-17
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. Patient willing to provide signed informed consent and willing to comply
with all required study schedule events, where safe and feasible.
2. Patient is male and aged >18 years old.
3. Histologically confirmed adenocarcinoma of the prostate.
4. Candidate for RP with PLND scheduled to undergo the surgical procedure.
5. Unfavorable intermediate risk (Gleason Grade Grouping [GGG] 2 with >=50% of
biopsy cores positive for PCa and/or >1 Intermediate Risk Factor [T2b; T2c; PSA
10-20] or Any GGG 3) or high risk or very high risk disease (per NCCN
Guidelines Version 2.2019; PROS-2).

Exclusion Criteria

1. Patients with any medical condition or circumstance (including receiving an
IP) that the investigator believes may compromise the data collected or lead to
a failure to fulfil the study requirements.
2. Patients who are planned to have an x-ray contrast agent or other PET
radiotracer <24 hours prior to the PET scan.
3. Patients currently receiving, or with a prior history of, androgen
deprivation therapy (ADT; defined as surgical orchidectomy; luteinizing
hormone-releasing hormone [LHRH] agonist alone [continuous or intermittent];
LHRH antagonist alone [continuous or intermittent]; administration or use of a
first generation or second generation anti androgen alone or in combination
with an LHRH agonist/antagonist).
4. Patients participating in an interventional clinical trial within 30 days
and having received an IP within five biological half-lives prior to
administration of rhPSMA-7.3 (18F).

Study & Design

• Study Type: Interventional
• Study Design: Not specified