Effect of Copper CU64 PSMA I&T scanning to detect potential disease spread to lymph nodes in men with newly diagnosed Prostate Cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Curium US LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Male Urogenital Diseases [C12]

Decision date (initial)

2024-09-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

Primary Objective and Endpoints To determine the diagnostic performance of copper Cu 64 PSMA I&T PET/CT for the detection of presence or absence of pelvic lymph node metastasis in pre-prostatectomy patients with unfavorable intermediate-risk, high-risk or very high-risk PC.

Secondary objectives 2

1. 1. To assess inter- and intra-reader agreement of copper Cu 64 PSMA I&T PET/CT interpretation on a per-patient basis.
2. 2. To assess the safety of copper Cu 64 PSMA I&T injection.

Conditions and MedDRA coding

Prostate cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 1. Patients with histologically proven prostate adenocarcinoma.
2. 2. Planned prostatectomy with pelvic lymph node dissection.
3. 3. Unfavorable intermediate-risk, high-risk, or very high-risk disease defined by NCCN Guidelines Version 1.2023 and previous versions.
4. 4. Male aged ≥18 years.
5. 5. Able to understand and provide signed written informed consent.

Exclusion criteria 7

1. 1. Androgen deprivation therapy, neoadjuvant chemotherapy, radiation therapy (including local ablation techniques), or any investigational therapy against PC prior to prostatectomy.
2. 2. Patients participating in an interventional clinical trial within 30 days and having received an IP within five (5) biological half-lives prior to administration.
3. 3. Patients with any medical condition or circumstance (including receiving an IP or capable of having a PET study) that the investigator believes may compromise the data collected or lead to a failure to fulfil the study requirements.
4. 4. Patients who are planned to have an x-ray contrast within 24 hours or other PET radiotracer < within 10 physical half-lives prior to the PET scan. If Barium contrast is administered this should be cleared before the PET scan.
5. 5. Patients who are administered any high energy (>300 KeV) gamma emitting radioisotopes within five (5) physical half-lives prior to copper Cu 64 PSMA I&T administration.
6. 6. Patients with known hypersensitivity to the active substance or any of the excipients of the IP.
7. 7. Patients who had a PSMA PET as part of their standard medical care within 90 days prior to enrollment

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 1. The sensitivity of copper Cu 64 PSMA I&T PET/CT to determine the presence of metastatic pelvic lymph nodes relative to histopathology reference standard. At least one positive pelvic lymph node on the PET scan and one positive lymph node as determined by histopathology on the same side of the pelvis (left or right) will be counted a true positive at the patient level.
2. 2. The specificity of copper Cu 64 PSMA I&T PET/CT to determine the absence of metastatic pelvic lymph nodes relative to histopathology reference standard. Negative pelvic lymph node on the PET scan and negative pelvic lymph nodes as determined by histopathology on the same side of the pelvis (Left or Right) will be counted a true negative at the patient level.

Secondary endpoints 2

1. 1. Reader kappa statistics of copper Cu 64 PSMA I&T PET/CT scan interpretation by the blinded independent readers.
2. 2. Treatment-emergent adverse events from the time of IP administration up to 72 hours.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Curium US LLC

Sponsor organisation

Curium US LLC

Address

2703 Wagner Place

City

Maryland Heights

Postcode

63043-3421

Country

United States

Scientific contact point

Organisation

Curium US LLC

Contact name

Anni Morsing, Curium Denmark

Public contact point

Organisation

Curium US LLC

Contact name

General Manager, Curium PET France

Third parties 6

Locations

3 EU/EEA countries · 31 investigational sites

By country

Investigational sites

Application history

1 submissions — initial application plus substantial / non-substantial modifications