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

NCT05847348 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 68Ga-PSMA-11-001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 8

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 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.

Conditions

Biochemical Recurrence of Malignant Neoplasm of Prostate; Prostate Cancer; BCR Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (2)

• Incidence of adverse events

  3 days

• Clinical management in biochemical recurrence patients.

  3 days

Study Arms (1)

Treatment (68Ga-PSMA-11)

EXPERIMENTAL

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; Other: PET/CT or PET/MRI

Interventions

68Ga-PSMA-11 DRUG

A single dose of 111 - 259 MBq administered intravenously over 3 -5 minutes

Also known as: Illucix, gallium Ga 68 Gozetotide

Treatment (68Ga-PSMA-11)

PET/CT or PET/MRI OTHER

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

Also known as: Imaging by PET

Treatment (68Ga-PSMA-11)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Prostate cancer is limited to males only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are able to understand and provide written informed consent document.
• Are Chinese males aged ≥ 18 years.
• 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).
• Post radical prostatectomy (RP) PSA ≥0.2 ng/mL measured 6 weeks after RP
• Post radiation therapy - ASTRO-Phoenix consensus definition Nadir + ≥ 2 ng/mL rise in PSA;
• Have a Karnofsky performance status ≥ 60 (or ECOG/WHO equivalent).
• Agree to practice a highly effective method of contraception for at least 28 days after 68Ga-PSMA-11 administration.
• Are willing and able to comply with scheduled

You may not qualify if:

• 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.
• Have prior use of radionuclides with an interval of less than 10 physical half-lives before the administration of 68Ga-PSMA-11.
• Are participating or plan to participate in any drug or device clinical study during the study period.
• Have a known hypersensitivity to the active ingredient or its components of 68Ga-PSMA-11.
• Cannot lie flat or remain still while a PET scan is being performed or cannot tolerate a PET scan.
• Have prior history of salivary gland disease or Paget's disease.
• Have a history of fracture and anemia within the last year.
• 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.
• Is deemed not suitable for participating in this trial in the opinion of the investigator.

Sponsors & Collaborators

• Telix Pharmaceuticals (Innovations) Pty Limited: lead
• Grand Pharmaceutical (China) Co., Ltd.: collaborator

Study Sites (8)

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

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study aims to recruit 110 prostate cancer patients with elevated PSA (BCR) after radical prostatectomy or radical radiotherapy

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: May 6, 2023
• Study Start: July 19, 2023
• Primary Completion: December 30, 2025
• Study Completion (Estimated): July 30, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)