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

Phase 3

Completed

• Conditions: Prostate cancer; 10027656

• Registration Number: NL-OMON50086
• Lead Sponsor: Blue Earth Diagnostics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2021-12-15
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

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. Patient with a history of localized adenocarcinoma of the prostate with
prior curative intent treatment, experiencing BCR of PCa potentially eligible
for salvage therapy with curative intent, following prior treatment with one or
more of the following: a) RP, b) RP plus adjuvant RT, c) RP plus adjuvant
androgen deprivation therapy (ADT), d) external beam radiation therapy or e)
focal gland therapies (e.g. brachytherapy, high-intensity focused ultrasound
[HIFU]).
- At least 6 weeks must have elapsed after RP.
- If previously taking ADT, it should have been discontinued at least 16 weeks
prior to screening.
- In the case of focal gland therapies (e.g. HIFU) and RT, the treatment will
have occurred at least 1 year prior to screening.
4. An elevated PSA, clinically suspicious for biochemically recurrent disease:
- Following RP: initial PSA >=0.2 ng/mL followed by a subsequent confirmatory
PSA value >=0.2 ng/mL.
- Following RT (e.g. radical radiotherapy or brachytherapy): nadir +2 ng/mL.
- Following focal gland therapies (e.g. HIFU): nadir +2 ng/mL
5. Patient willing to undergo biopsy for histological confirmation of
rhPSMA-7.3 (18F) PET findings, where safe and feasible.

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 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