What is 68Ga-PSMA-11 studying for prostate cancer?

68Ga-PSMA-11 is being studied to see how well it detects recurrent prostate cancer in patients with rising PSA levels after initial treatment. This trial, sponsored by Telix Pharmaceuticals, evaluates the diagnostic accuracy of PET/CT or PET/MRI scans using this imaging tracer. Participants can expect a single injection followed by a detailed scan to identify cancer recurrence.

Who may be eligible for this prostate cancer clinical trial?

Men aged 18 years or older with confirmed prostate adenocarcinoma who have undergone radical prostatectomy or radiotherapy and now show biochemical recurrence of PSA may be eligible. Participants must be able to lie still for imaging and agree to contraception use after the scan. Please review eligibility criteria for more details.

Is there any cost to participate in this prostate cancer clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs related to travel or accommodations.

Actively Recruiting

Phase 3

Age: 18Years +

MALE

ID05847348

A Prospective, Open-Label, Single-Arm, Multi-center Study to Evaluate the Diagnostic Efficacy and Safety of 68Ga-PSMA-11 PETCT or PETMRI in Patients With Biochemical Recurrent Prostate Cancer

Led by Telix Pharmaceuticals (Innovations) Pty Limited · Updated on 2024-07-03

110

Participants Needed

Research Sites

30 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of 68Ga-PSMA-11 PETCT or PETMRI imaging in detecting biochemical recurrence of prostate cancer in Chinese male patients who have elevated PSA levels after radical prostatectomy or radiotherapy. This Phase 3, prospective, open-label, single-arm, multicenter study focuses on patients with confirmed prostate adenocarcinoma experiencing biochemical recurrence. The study seeks to understand how well the imaging tracer 68Ga-PSMA-11, also known as Illuccix, works in this population. Participants will receive a single intravenous dose of 68Ga-PSMA-11, ranging from 111 to 259 MBq, administered over 3 to 5 minutes. After 50 to 100 minutes post-injection, they will undergo PETCT or PETMRI scanning from mid-thigh to the skull while lying on their back with their arms overhead. This imaging procedure is designed to detect recurrent tumor sites. During the study, participants will be monitored for up to 12 months to assess the positive predictive value of 68Ga-PSMA-11 imaging based on biopsy, clinical follow-up, and conventional imaging. Adverse events and changes in clinical management will be tracked for 3 days post-imaging. Participants must comply with scheduled visits and assessments, including PSA measurements and safety evaluations, throughout the study.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

MALE

Eligibility Criteria

You may qualify if you...

Able to understand and provide written informed consent.
Chinese male aged 18 years or older.
Histopathologically confirmed prostate adenocarcinoma with prior radical prostatectomy and/or radical radiotherapy.
Evidence of biochemical recurrence: PSA 6 0.2 ng/mL at least 6 weeks after prostatectomy or a rise of 6 2 ng/mL above nadir after radiation therapy.
Karnofsky performance status of 60 or higher (or ECOG/WHO equivalent).
Agree to use highly effective contraception for at least 28 days after 68Ga-PSMA-11 administration.
Willing and able to comply with scheduled study procedures.

You will not qualify if you...

History of other malignancy within past year, except non-metastatic skin basal cell or superficial squamous cell carcinoma and superficial bladder cancer.
Prior radionuclide therapy within an interval of less than 10 physical half-lives before 68Ga-PSMA-11 administration.
Participation in any other drug or device clinical study during this study period.
Known allergy to 68Ga-PSMA-11 or its components.
Unable to lie flat or remain still for PET scan.
History of salivary gland disease or Paget's disease.
History of fracture or anemia within last year.
Abnormal physical exam, ECG, or lab tests affecting safety or compliance.
Investigator deems participant unsuitable for the trial.

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