A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer.

This study is open to men aged 18 or older who have been recently diagnosed with prostate cancer that hasn't spread to other parts of the body. You must be suitable for an operation to remove your prostate, and your cancer must be classified as intermediate, high, or very high risk.

To join, your general health, including your blood and other organ functions, must be good enough to participate safely. You will also need to provide formal written agreement to take part, and if you choose, to allow optional genetic research on your samples. Available biopsy samples of your tumour will also be needed.

There are some reasons why you wouldn't be able to join. These include having other severe health conditions like uncontrolled bleeding problems or active infections such as hepatitis or HIV. If you have a history of certain blood disorders (like MDS/AML) or other recent serious illnesses in the last three years, or known heart problems that could be affected by the study drugs, you would not be eligible.

If you decide to take part, you'll be assigned to receive either Saruparib alone, Darolutamide alone, or both drugs together. You'll take this medication for a period before your planned prostatectomy (surgery to remove the prostate). Throughout the study, you'll have regular visits to the clinic for check-ups, blood tests, and other assessments to monitor your health and see how the treatment is affecting the cancer. Researchers will also collect tissue samples during your surgery to understand the drugs' effects. You'll need to use contraception (condoms with spermicide) and not father a child during the study and for 6 months afterwards. The total duration of your involvement, including follow-up after surgery, will be explained to you by the study team.