Status:

RECRUITING

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

Lead Sponsor:

Telix Pharmaceuticals (Innovations) Pty Limited

Collaborating Sponsors:

Grand Pharmaceutical (China) Co., Ltd.

Conditions:

Biochemical Recurrence of Malignant Neoplasm of Prostate

Prostate Cancer

Eligibility:

MALE

18+ years

Phase:

PHASE3

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 recur...

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.

Key Trial Info

Start Date :

July 19 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 30 2026

Estimated Enrollment :

110 Patients enrolled

Trial Details

Trial ID

NCT05847348

Start Date

July 19 2023

End Date

July 30 2026

Last Update

July 3 2024

Active Locations (8)

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Page 1 of 2 (8 locations)

1

Peking University First Hospital

Beijing, China

2

Xiangya Hospital Central South University

Changsha, China

3

Nanfang Hospital Southern Medical University

Guangzhou, China

4

Fudan University Shanghai Cancer Center

Shanghai, China