Clinical trial NCT05847348: 68Ga-PSMA-11 Efficacy in Detecting BCR Prostate Cancer in Chinese Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Biochemical Recurrence of Malignant Neoplasm of Prostate
Prostate Cancer
BCR Prostate Carcinoma
Lead sponsor: Telix Pharmaceuticals (Innovations) Pty Limited
Sponsor class: INDUSTRY
Collaborators: name: Grand Pharmaceutical (China) Co., Ltd.
First posted: 2023-05-06
Enrollment: 110
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study aims to recruit 110 prostate cancer patients with elevated PSA (BCR) after radical prostatectomy or radical radiotherapy
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: 3 days
measure: Clinical management in biochemical recurrence patients.
timeFrame: 3 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
city: Changsha
country: China
facility: Xiangya Hospital Central South University
city: Guangzhou
country: China
facility: Nanfang Hospital Southern Medical University
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Sichuan
country: China
facility: West China Hospital of Sichuan University
city: Wuhan
country: China
facility: Wuhan Union Hospital
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
city: Wuxi
country: China
facility: Affiliated Hosptial of Jiangnan University
Study officials:
References: