Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer

This study is looking for men aged 18 or over who have had prostate cancer. You would be considered if your prostate cancer was treated with surgery or radiotherapy, and your PSA levels have started to rise again within three years of that treatment. It's important that imaging scans (like CT or bone scans) show no signs of the cancer having spread to other parts of your body.

If you had surgery, your PSA must be 0.2 ng/mL or higher, and your PSA doubling time (how quickly your PSA levels are rising) needs to be between 3 and 12 months. If you had radiotherapy, your PSA must be at least 2 ng/mL higher than its lowest point after treatment, and your PSA doubling time also needs to be between 3 and 12 months.

There are also some reasons you might not be able to join. For example, if you are currently receiving or are planned to start hormone therapy (androgen-deprivation therapy), or if your PSA is very high (above 10 ng/mL). You also can't have already had or be planning to have further intensive treatments like salvage radiotherapy or further surgery for your prostate cancer.

If you decide to take part, you would be randomly assigned to receive either the new vaccine (RV001V) or a placebo (a dummy treatment). You would receive regular injections over a period. Throughout the study, you would attend scheduled clinic visits for blood tests, physical examinations, and to discuss any side effects you might be experiencing. These visits help the study team monitor your health and the treatment's effect. You'll also have scans to check on your prostate cancer. The total duration of the study, including the treatment period and follow-up, would be discussed in detail with you by the study team, but typically involves several months of treatment followed by ongoing monitoring.