Using 68Ga-PSMA-11 to detect prostate cancer recurrence in Chinese patients
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
This study is testing a new imaging method to see if it can help find prostate cancer that has come back in Chinese men who have already had surgery or radiation treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Telix Pharmaceuticals (Innovations) Pty Limited Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 8 sites (Beijing and 7 other locations) |
| Trial ID | NCT05847348 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the effectiveness of 68Ga-PSMA-11 PET/CT imaging in detecting biochemical recurrence of prostate cancer in Chinese males who have previously undergone radical prostatectomy or radiotherapy. It is a prospective, open-label, single-arm, multicenter study that will enroll patients with elevated PSA levels following their initial treatment. The study will assess how well this new molecular tracer can identify recurrent cancer, potentially improving patient management and outcomes.
Who should consider this trial
Good fit: Ideal candidates are Chinese males aged 18 and older with a confirmed diagnosis of prostate adenocarcinoma who have experienced biochemical recurrence after radical prostatectomy or radiotherapy.
Not a fit: Patients with a history of other malignancies within the last year, except for certain skin cancers, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of prostate cancer recurrence detection, leading to better treatment decisions for patients.
How similar studies have performed: Other studies using similar imaging techniques have shown promise in detecting prostate cancer recurrence, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing and 7 other locations
- Peking University First Hospital — Beijing, China (Recruiting)
- Xiangya Hospital Central South University — Changsha, China (Recruiting)
- Nanfang Hospital Southern Medical University — Guangzhou, China (Recruiting)
- Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)
- West China Hospital of Sichuan University — Sichuan, China (Recruiting)
- Wuhan Union Hospital — Wuhan, China (Recruiting)
- Zhongnan Hospital of Wuhan University — Wuhan, China (Recruiting)
- Affiliated Hosptial of Jiangnan University — Wuxi, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.