Recurrent and metastatic prostate cancer: Impact of 18F-PSMA-1007 PET/CT on clinical decision making and response monitoring

The RE-PRISMA PhD project:

Recurrent and Metastatic Prostate Cancer:
Impact of 18F-PSMA-1007 PET/CT on clinical decision making and response monitoring

EudraCT number 2021-000184-78

The overall goal of this project is to develop a personalized assessment regime for patients with recurrent and metastatic Prostate Cancer (PCa), where we aim to tailor the diagnostic work-up, treatment, and response monitoring to the molecular profile. The project consists of two separate studies:

• In RE-PRISMA 1 we hypothesize that 18F-PSMA-PET/CT and 18F-PSMA-PET/MR will improve pretreatment assessment of spread and PSMA-receptor heterogeneity in recurrent PCa, and contribute to make more confident treatment choices regarding salvage radiotherapy and systemic therapy.

• In RE-PRISMA 2 we hypothesize that 18F-PSMA-PET/CT and WB MRI will give a more accurate assessment of metastatic castration resistant PCa than conventional methods and will be more accurate in disease monitoring. We intend to identify early treatment resistance with the potential of revealing new treatment targets.

Related policies:
The Re-PRISMA project is approved by the Ethic Committee in Region of Southern Denmark (ID-no.: S-20190080, 1. version 22 September 2019 and 2. version August 26 2021).

The RE-PRISMA project complies with the Data protection Act on Processing of Personal Data and is approved and registered by the Data Protection Regulation in the Region of Southern Denmark (Journal no: 19/36612, 1. version 18 September 2019 and 2. version 15 October 2021).

The RE-PRISMA part 2 project is approved as a Clinical Trial of Medicines by The Danish Medicines Agency for the PSMA used in the research scans. It is monitored as a Good Clinical Practice Trial by the local GCP-unit, OPEN, J.B. Winsløws Vej 9, 5000 Odense C (Protocol number 2020110470, EudraCT-number 2021-000184-78, 1. version 22 June 2021).

Grants:

1-year salary including student fee is granted from SDU Faculty scholarship, Department of Health Sciences.

1-year salary including student fee is granted from the OUH PhD fund (EAN no. 5798002502541, account number 10212348).

1-year salary including student fee is guaranteed from PREMIO; Centre for response monitoring in Oncology, OUH, including half of the running costs for scans only in the project (EAN no. 5798002502541, account number 10240197).DKK 10.000 for a small part of the TAP salary is granted from “Overlægerådets forskningsfond”, OUH (EAN no. 5798002502541, account no. 10212348).