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

June 29, 2024 updated by: Telix Pharmaceuticals (Innovations) Pty Limited

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University First Hospital
        • Contact:
        • Principal Investigator:
          • Yan Fan
      • Changsha, China
        • Recruiting
        • Xiangya Hospital Central South University
        • Principal Investigator:
          • Shuo Hu
        • Contact:
      • Guangzhou, China
        • Recruiting
        • Nanfang Hospital Southern Medical University
        • Principal Investigator:
          • Wanlong Tan
        • Contact:
      • Shanghai, China
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
        • Principal Investigator:
          • Shaoli Song
      • Sichuan, China
        • Recruiting
        • West China Hospital of Sichuan University
        • Sub-Investigator:
          • Pengfei Shen
        • Contact:
        • Principal Investigator:
          • Lin Li
      • Wuhan, China
        • Recruiting
        • Wuhan Union Hospital
        • Contact:
        • Principal Investigator:
          • Xiaoli Lan, PhD
      • Wuhan, China
        • Recruiting
        • Zhongnan Hospital of Wuhan University
        • Principal Investigator:
          • Yong He
        • Contact:
      • Wuxi, China
        • Recruiting
        • Affiliated Hosptial Of Jiangnan University
        • Contact:
        • Principal Investigator:
          • Chunjing Yu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (68Ga-PSMA-11)

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
A single dose of 111 - 259 MBq administered intravenously over 3 -5 minutes
Other Names:
  • Illucix
  • gallium Ga 68 Gozetotide
Other: PET/CT or PET/MRI
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
Other Names:
  • Imaging by PET

What is the study measuring?

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.
Time Frame: 12 months
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
Time Frame: 3 days
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.
Time Frame: 3 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Telix Pharmaceuticals (Innovations) Pty Limited

Collaborators

Grand Pharmaceutical (China) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2023

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

April 5, 2023

First Submitted That Met QC Criteria

April 26, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

June 29, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 68Ga-PSMA-11-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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