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

Launched by TELIX PHARMACEUTICALS (INNOVATIONS) PTY LIMITED · Apr 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging test called 68Ga-PSMA-11 to see how well it can detect prostate cancer that has returned after treatment in Chinese men. The trial includes patients who have had surgery or radiation therapy for prostate cancer and are now experiencing a rise in their PSA levels, which is a marker for cancer activity. The study aims to find out how effective this test is at identifying the cancer during this stage, known as biochemical recurrence.

To be eligible for the trial, participants must be Chinese males aged 18 or older with a confirmed diagnosis of prostate cancer who have undergone previous treatments and have shown increased PSA levels. Participants should be able to provide consent, meaning they understand what the study involves. During the trial, patients will receive the 68Ga-PSMA-11 test and undergo a PET scan, which is a specific type of imaging that helps doctors see if there are any cancer cells present. It's important for potential participants to note that they need to follow certain guidelines and may be excluded if they have specific health issues or have participated in other clinical studies recently.

Gender

MALE

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.