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

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Open-Label, Single-Arm, Multi-center Study to Evaluate the Diagnostic Efficacy and Safety of 68Ga-PSMA-11 PET/CT or PET/MRI in Patients With Biochemical Recurrent Prostate Cancer

Conditions
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Biochemical Recurrence of Malignant Neoplasm of Prostate, Prostate Cancer, BCR Prostate Carcinoma

Intervention / Treatment
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* Drug: 68Ga-PSMA-11
* Other: PET/CT or PET/MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are able to understand and provide written informed consent document. Are Chinese males aged ≥ 18 years. 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). Post radical prostatectomy (RP) PSA ≥0.2 ng/mL measured 6 weeks after RP Post radiation therapy - ASTRO-Phoenix consensus definition Nadir + ≥ 2 ng/mL rise in PSA; Have a Karnofsky performance status ≥ 60 (or ECOG/WHO equivalent). Agree to practice a highly effective method of contraception for at least 28 days after 68Ga-PSMA-11 administration. Are willing and able to comply with scheduled Exclusion Criteria: 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. Have prior use of radionuclides with an interval of less than 10 physical half-lives before the administration of 68Ga-PSMA-11. Are participating or plan to participate in any drug or device clinical study during the study period. Have a known hypersensitivity to the active ingredient or its components of 68Ga-PSMA-11. Cannot lie flat or remain still while a PET scan is being performed or cannot tolerate a PET scan. Have prior history of salivary gland disease or Paget's disease. Have a history of fracture and anemia within the last year. 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. Is deemed not suitable for participating in this trial in the opinion of the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: This study aims to recruit 110 prostate cancer patients with elevated PSA (BCR) after radical prostatectomy or radical radiotherapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (68Ga-PSMA-11)<br>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. | Drug: 68Ga-PSMA-11<br>* A single dose of 111 - 259 MBq administered intravenously over 3 -5 minutes<br>* Other names: gallium Ga 68 Gozetotide;Other: PET/CT or PET/MRI<br>* PET/CT or PET/MRI will be acquired no sooner than 50 minutes post injection and not later than 100 minutes post injection with 68Ga-PSMA-11<br>* Other names: Imaging by PET;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Predictive Value (PPV) of 68Ga-PSMA-11 PET/CT or PET/MRI for detection of tumour on a patient level confirmed by histopathology/biopsy, clinical (PSA) and conventional imaging follow-up. | The PPV [PPV (%) = TP* /(TP + FP**)] will be determined by the combination of histopathology/biopsy and conventional imaging and/or PSA follow-up results as the true criteria (composite criteria) and the results observed by 68Ga-PSMA-11 PET (positive/negative). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Safety will be reported descriptively as rates of patient reported adverse events. Additionally, adverse events will be characterized and quantified by Common Terminology Criteria for Adverse Events | 3 days | 
| Clinical management in biochemical recurrence patients. | The impact of 68Ga-PSMA-11 PET/CT or PET/MRI on clinical management in biochemical recurrence patients will be assessed through the completion of Medical Management Questionnaires completed prior to and after 68Ga-PSMA-11 PET/CT or PET/MRI. | 3 days |