Trial Title:
68Ga-PSMA-11 Efficacy in Detecting BCR Prostate Cancer in Chinese Patients
NCT ID:
NCT05847348
Condition:
Biochemical Recurrence of Malignant Neoplasm of Prostate
Prostate Cancer
BCR Prostate Carcinoma
Conditions: Official terms:
Prostatic Neoplasms
Neoplasms
Recurrence
Gallium 68 PSMA-11
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
68Ga-PSMA-11
Description:
A single dose of 111 - 259 MBq administered intravenously over 3 -5 minutes
Arm group label:
Treatment (68Ga-PSMA-11)
Other name:
Illucix
Other name:
gallium Ga 68 Gozetotide
Intervention type:
Other
Intervention name:
PET/CT or PET/MRI
Description:
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
Arm group label:
Treatment (68Ga-PSMA-11)
Other name:
Imaging by PET
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.
Criteria for 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.
Gender:
Male
Gender based:
Yes
Gender description:
Prostate cancer is limited to males only
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University First Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Phone:
0086-010-83572732
Email:
info@telixpharma.com
Investigator:
Last name:
Yan Fan
Email:
Principal Investigator
Facility:
Name:
Xiangya Hospital Central South University
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Phone:
0086-0731-89752051
Email:
info@telixpharma.com
Investigator:
Last name:
Shuo Hu
Email:
Principal Investigator
Facility:
Name:
Nanfang Hospital Southern Medical University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Phone:
0086-020-62783210
Email:
info@telixpharma.com
Investigator:
Last name:
Wanlong Tan
Email:
Principal Investigator
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Phone:
0086-021-64175590-88900
Email:
info@telixpharma.com
Investigator:
Last name:
Shaoli Song
Email:
Principal Investigator
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Sichuan
Country:
China
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Phone:
0086-028-85423532
Email:
info@telixpharma.com
Investigator:
Last name:
Lin Li
Email:
Principal Investigator
Investigator:
Last name:
Pengfei Shen
Email:
Sub-Investigator
Facility:
Name:
Wuhan Union Hospital
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Phone:
0086-027-83692633
Email:
info@telixpharma.com
Investigator:
Last name:
Xiaoli Lan, PhD
Email:
Principal Investigator
Facility:
Name:
Zhongnan Hospital of Wuhan University
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Phone:
0086-027-67813181
Email:
info@telixpharma.com
Investigator:
Last name:
Yong He
Email:
Principal Investigator
Facility:
Name:
Affiliated Hosptial of Jiangnan University
Address:
City:
Wuxi
Country:
China
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Phone:
0086-0510-68089397
Email:
info@telixpharma.com
Investigator:
Last name:
ChunJing Yu
Email:
Principal Investigator
Start date:
July 19, 2023
Completion date:
July 30, 2026
Lead sponsor:
Agency:
Telix Pharmaceuticals (Innovations) Pty Limited
Agency class:
Industry
Collaborator:
Agency:
Grand Pharmaceutical (China) Co., Ltd.
Agency class:
Other
Source:
Telix Pharmaceuticals (Innovations) Pty Limited
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05847348
