Prostate cancer
Prostate cancer is the most commonly diagnosed male cancer and a leading cause of death in men. Worldwide. In 2020 more than 1.4 million men were diagnosed, and >375,000 died from their disease (WHO, 2020).
Prostate-specific membrane antigen (PSMA) is a transmembrane protein expressed on many neoplastic and intrinsic tissues. PSMA is highly expressed on prostate epithelial cells and strongly upregulated in prostate cancer and, particularly, advanced prostate cancer.
Telix is investigating PSMA as a potential target for prostate cancer theranostics.
For more information on Telix’s clinical trials in prostate cancer please see trial descriptions below, clickable through to clinical trial database where registered:
Therapy: ProstACT GLOBAL (Phase III, Initiating)
A Multinational, Multicenter, Prospective, Randomized, Controlled, Open Label Phase III Study With Best Standard of Care With and Without TLX591 (
177Lu-DOTA-rosopatamab) for Patients With PSMA Expressing Metastatic Castration-resistant Prostate Cancer Progressing Despite Prior Treatment With a Novel Androgen Axis Drug.
Therapy: ProstACT TARGET (Phase II, Recruiting)
This study is evaluating the therapeutic efficacy of a radiolabelled PSMA-targeting antibody, TLX591, given in combination with external beam radiation therapy (EBRT) in patients with biochemically recurrent, oligometastatic, PSMA-expressing prostate cancer.
Therapy: ProstACT SELECT (Phase I, Recruiting)
This study is assessing the safety and tolerability, pharmacokinetics, whole body biodistribution and radiation dosimetry of TLX591.
Therapy: CUPID (Phase I, Recruiting)
A Phase I, Single Centre, Open-label Study of TLX592 to Assess the Safety and Tolerability, Pharmacokinetics, Biodistribution and Radiation Dosimetry in Patients Diagnosed With Prostate Cancer.
Imaging: China Registration Study (Phase III, Recruiting)
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 patients.
Imaging: NOBLE Registry (Recruiting)
A global consortium of 8 investigator-led studies collecting prospective, real-world clinical data on the use of TLX599-CDx. The objective is to generate a data repository – which may inform further development of PSMA-SPECT products for emerging markets.
Imaging: University of Linz (Phase III, Complete)
A comparative study of 68Ga-PSMA-11 PET/CT and 18F-fluorocholine PET/CT in the detection of recurrence in prostate cancer patients after radical treatment.
Imaging: Emory University (Phase II, Recruiting)
Evaluating how positron emission tomography (PET)/computed tomography (CT) using fluciclovine F18 compares with a PET/CT scan with
68Ga-PSMA in planning radiation treatments and enhancing outcomes in patients with prostate adenocarcinoma.
Imaging: Memorial Sloan Kettering (Phase II, Recruiting)
Exploring whether a new diagnostic research agent named
68Ga-HBED-CC-PSMA can show prostate cancer on a PET/CT scan that cannot be seen on other standard imaging even when the PSA levels are very low.
