The aim of this trial is to determine how patients with advanced, hormone-resistant prostate cancer with evidence of a homologous recombination gene deficiency respond to rucaparib (Rubraca) treatment. The main outcome to be measured is the response to treatment, and changes to prostate-specific antigen levels (a protein present in prostate cancer).
The details
A main treatment option for prostate cancer is androgen-deprivation therapy. This blocks the activity of male hormones (such as testosterone) involved in cancer growth. Some men become resistant to this treatment, and the cancer may spread outside of the prostate gland into surrounding organs. This is known as metatstatic castration-resistant prostate cancer. Some men with prostate cancer may also have a homologous recombinant gene deficiency. This is when there is a change in the genes that leads to the development of new gene variations. These variations may lead to the development of cancer. Rucaparib blocks the action of certain proteins invlvoed in cancer growth. t is being developed for the treatment of advanced, hormone-resistant prostate cancer.
This study will examine the response to rucaparib treatment in men with advanced, hormone-resistant prostate cancer who have a homologous recombinant gene deficiency.
Who are they looking for?
160 men over the age of 18 years who have confirmed adenocarcinoma will be eligible for selection. Men who have been medically castrated, or who have experienced disease progression after hormone therapy will be eligible. Men with mutations in specific genes or evidence of homologous recombination deficiency will be eligible for selection.
Men with co-existing diseases or cancers, such as central nervous system, stomach, and intestinal diseases, will not be considered eligible for selection. Men who have received prior treatment with a PARP inhibitor or chemotherapy will not be eligible for this trial.
How will it work
Patients will receive rucaparib orally, once daily. The response to treatment and changes to PSA levels will be measured over 3 years. Side effects and time to progression will be measured over 3 years, 6 months.
