68Ga-PSMA-11 Efficacy in Detecting BCR Prostate Cancer in Chinese Patients

Telix Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Biochemical Recurrence of Malignant Neoplasm of Prostate; BCR Prostate Carcinoma; Prostate Cancer

Treatments: Drug: 68Ga-PSMA-11; Other: PET/CT or PET/MRI

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05847348

68Ga-PSMA-11-001

Details and patient eligibility

About

This is a prospective, open-label, single-arm, multicenter bridging study in Chinese patients with prostate cancer. This multicenter study is planned to be conducted in patients with biochemical recurrence (BCR) of elevated PSA after radical prostatectomy or radical radiotherapy. This study investigates how well 68Ga-PSMA-11 PET/CT works in detecting BCR prostate cancer in Chinese patient. 68Ga-PSMA-11, developed by Telix, is a new molecular entity tracer with the trade name Illuccix®, which is approved by FDA for the examination of: 1) patients with suspected metastatic PC who are scheduled for initial treatment; 2) patients with biochemical recurrence of elevated PSA levels after initial radical radiotherapy.

Enrollment: 110 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Are able to understand and provide written informed consent document.

2. Are Chinese males aged ≥ 18 years.

3. Have histopathologically confirmed prostate adenocarcinoma and have undergone radical prostatectomy and/or radical radiotherapy and experienced biochemical recurrence (PSA should be measured within 30 days of screening).

   1. Post radical prostatectomy (RP) PSA ≥0.2 ng/mL measured 6 weeks after RP
   2. Post radiation therapy - ASTRO-Phoenix consensus definition Nadir + ≥ 2 ng/mL rise in PSA;

4. Have a Karnofsky performance status ≥ 60 (or ECOG/WHO equivalent).

5. Agree to practice a highly effective method of contraception for at least 28 days after 68Ga-PSMA-11 administration.

6. Are willing and able to comply with scheduled

Exclusion criteria

1. Have a prior history of any other malignancy within the last year, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
2. Have prior use of radionuclides with an interval of less than 10 physical half-lives before the administration of 68Ga-PSMA-11.
3. Are participating or plan to participate in any drug or device clinical study during the study period.
4. Have a known hypersensitivity to the active ingredient or its components of 68Ga-PSMA-11.
5. Cannot lie flat or remain still while a PET scan is being performed or cannot tolerate a PET scan.
6. Have prior history of salivary gland disease or Paget's disease.
7. Have a history of fracture and anemia within the last year.
8. Have abnormalities in physical examination, ECG, and protocol-specified clinical laboratory tests during the Screening Period that, in the judgment of the investigator, could affect safety or compliance.
9. Is deemed not suitable for participating in this trial in the opinion of the investigator.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Treatment (68Ga-PSMA-11)

Experimental group

Description:

111 \~ 259 MBq 68Ga-PSMA-11 will be administered intravenously to participants over 3- 5 minutes. After 50-100 minutes post 68Ga-PSMA-11 injection, participants will be scanned (PET/CT or PET/MRI) from the mid-thigh to the apex of the skull. Participants will be placed in a supine position with the arms raised overhead.

Treatment:

Other: PET/CT or PET/MRI

Drug: 68Ga-PSMA-11