Cyclotek’s Chief Medical Officer, Dr Rob Ware and the Australasian Association of Nuclear Medicine Specialists (AANMS), applied to the Medical Services Advisory Committee (MSAC) in March 2020 for prostate-specific (PSMA) PET radiopharmaceuticals (including 18F-DCFPyL and 68Ga-PSMA) to be funded under the medical benefits scheme (MBS).
In August 2020 MSAC agreed to receive an Applicant Developed Assessment Report (ADAR) detailing the scientific and economic case for considering MBS funding of PSMA PET scanning in men with prostate cancer at the time of initial staging and in the event of biochemical recurrence. The ADAR was developed by a team of experts at Health Technology Analysts in conjunction with Dr Ware and AANMS. The ADAR was lodged with MSAC in February 2021, and we look forward to active participation in progressing the submission to a positive outcome.
You can follow our progress through the MSAC process here.
Cyclotek would like to thank our key partners, the Australian Government as part of its CRC Projects Program, GE Healthcare and Macquarie University, for their assistance with the development, implementation and expansion of 18F-DCFPyL manufacturing and distribution capabilities and the MSAC submission development.
In October 2015, Cyclotek attained exclusive rights to the PSMA PET tracer 18F-DCFPyL from Johns Hopkins University. This entitled Cyclotek to manufacture and supply the Australian and New Zealand marketplace with 18F-DCFPyL as a prostate-specific radiopharmaceutical (PSR).
Cyclotek’s first GMP batch of PSR for patient use was supplied on 15 November 2016, following extensive development in materials management, synthesis, purification, automation, quality control and sterility assessments and its full process validation.
Since commencing manufacture, Cyclotek have supplied more than 14,000 PSR doses and supported eight clinical trials; including four studies to assess the efficacy of PSR for specific disease states in comparison to other diagnostic modalities.
Cyclotek currently supplies PSR as an extemporaneously compounded PET radiopharmaceutical made to order by customers for particular persons, through the Special Access Schemes (SAS), Authorised Prescriber and clinical trials. TGA recently migrated 18F-DCFPyL onto the SAS category C listing, which streamlines use for clinicians.
Internationally, Lantheus Holdings has submitted a New Drug Application to the U.S. FDA for PyL™ (18F-DCFPyL), as a PSMA-Targeted Prostate Cancer imaging agent.
Furthermore, Lantheus has announced publication of PyL™ (18F-DCFPyL) results from pivotal studies:
About Prostate Cancer in Australia and New Zealand
Prostate Cancer is the second most common cancer diagnosed in Australian men (>19,000 cases annually)[1] and the most common cancer in New Zealand men (> 3,000 cases annually)[2]. One in six Australian men and one in thirteen New Zealand men will develop prostate cancer before the age of 85.[3]
About 18F-DCFPyL (PSR)
Cyclotek has established regular bulk supply of prostate-specific radiopharmaceutical (18F-DCFPyL) to our customers throughout Australia and New Zealand. Similar to 18F-DCFPyL our bulk-manufacturing process allows multiple customers to be supported from a single batch of PSR, providing substantial efficiencies for production and distribution compared to 68Ga based PSMA radiopharmaceuticals. Typically, 68Ga-PSMA is produced at the imaging site with 2–3 patient doses available per session, whereas Cyclotek’s manufacturing process provides more than 35 doses of 18F-DCFPyL per production run.
18F radiopharmaceuticals have the advantage of longer half-life and higher scan resolution than 68Ga and can generally be administered in higher doses. These characteristics allow higher imaging quality for 18F PSMA agents, although clinical studies comparing 68Ga-labelled PSMA tracers with 18F-DCFPyL (PSR) indicate similar clinical effectiveness for localising sites of prostate cancer with PET/CT imaging.
18F-DCFPyL-PET (PSR) Clinical Trials in Australia
See a full listing of trials in the table below.
| Sponsor/PI | Trial Name | Trial Details |
| Genesis Care Pty Ltd | IMPORT | Impact of 18F-DCFPyL PET scanning in patients undergoing post-prostatectomy radiotherapy. |
| Peter MacCallum Cancer Institute | HEPASMART | Hepatocellular carcinoma imaging using PSMA PET/CT – a prospective pilot trial. |
| Mr Lih-Ming Wong | 236/17 | 18F-DCFPyL-PET for diagnosis of primary prostate cancer in men with positive mp MRI and negative biopsy. |
| St Vincent’s Hospital (Melbourne) | PEDAL#1 | A prospective single arm paired comparison of ability to diagnose and locate prostate cancer between multiparametric MRI and 18F-PSMA-PET/CT. |
| Pacific Radiology
[New Zealand] |
PEDAL#3 | A prospective single arm paired comparison of ability to diagnose and locate prostate cancer between multiparametric MRI and 18F-PSMA-PET/CT. |
| Professor Henry Woo | PMEHGMA | A clinical trial of PSMA PET /CT evaluation of high grade moMRI prostate abnormalities. |
| Cyclotek (Aust) Pty Ltd | COMPyL-001 | Evaluation of prostate specific membrane antigen expression in lesions diagnosed as prostate cancer using (2-(3-{1-Carboxy-5-[(6-[18F]Fluoro-Pyridine-3-Carbonyl)-Amino]-Pentyl}- Ureido)-Pentanedioic Acid) (18F DCFPyL) PET/CT imaging in men undergoing radical prostatectomy. |
| Olivia Newton John Cancer Institute | FDHT | [18F]-DIHYDRO-Testosterone PET imaging in patients with progressive prostate cancer. |
For further information please contact Mr. Greg Santamaria (CEO) or Dr. Rob Ware (CMO) at Enquiries@cyclotek.com
[1] Cancer Council: https://www.cancer.org.au/cancer-information/types-of-cancer/prosta.te-cancer
[2] Prostate Cancer Foundation: https://prostate.org.nz/prostate-cancer/
[3] Prostate Cancer Foundation: https://prostate.org.nz/prostate-cancer/
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