A Trial of Immunotherapy Strategies in Metastatic Hormone-sensitive Prostate Cancer
Status:
Active, not recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
Metastatic prostate cancer is an incurable disease that typically spreads beyond the
prostate. The standard of care is to systemically treat the disease with androgen deprivation
therapy (ADT). However, the disease progresses in virtually all patients to the state of
castration resistant prostate cancer (CRPC), with a median time to progression of 24 months.
Patients with high volume disease (with either visceral metastasis and/or bone metastasis)
exhibit a worse prognosis, with a median clinical progression of 14 months.
Recently, the CHAARTED and STAMPEDE studies demonstrated that the combination of Docetaxel
(chemotherapy) and ADT delayed the clinical progression and improved the survival a median of
14 months (17 for high volume patients). Nevertheless, the prognosis of patients with high
volume metastatic disease continues to be poor.
Meanwhile the immunotherapy, the use of antibodies that recognize tumoral cells and promote
the immune system activity against the cancer, has emerged as a very useful option in many
cancers. Among others, the antibodies Nivolumab and Ipilimumab have been approved for the
treatment of multiple types of cancer.
In this context, SOGUG (Spanish Oncology Genitourinary Group) has designed this new study
"PROSTRATEGY" with the objective of evaluating whether the addition of immunotherapy to
chemotherapy and ADT improves the prognosis and survival of patients with high volume
metastatic hormone-sensitive prostate cancer.