Study of diagnostic PET scan using rhPSMA-7.3 (18F) injection in men with suspected prostate cancer recurrence

Phase 1

• Conditions: Prostate cancer; MedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-003382-18-FI
• Lead Sponsor: Blue Earth Diagnostics Ireland Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-17
• Last Update Posted: 4 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 316

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, that meets one of the following conditions:
- Following RP with or without adjuvant or salvage therapy: 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) as the primary treatment: nadir +2 ng/mL.
- Following focal gland therapies (e.g. HIFU) as the primary treatment: nadir +2 ng/mL.

5. Patient willing to undergo biopsy for histological confirmation of rhPSMA-7.3 (18F) PET findings, where safe and feasible.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 190
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 126

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).

5. Patients with known hypersensitivity to the active substance or to any of the excipients of the IP.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified