NCT03879122

A Trial of Immunotherapy Strategies in Metastatic Hormone-sensitive Prostate Cancer

A Multi-arm, Multi-stage, Randomized Phase II/III Trial of Immunotherapy Strategies in Metastatic Hormone-sensitive Prostate Cancer

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Spanish Oncology Genito-Urinary Group · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Hormone-sensitive Prostate Cancer

Interventions

Type	Name	Description
DRUG	Ipilimumab 5 MG/ML	Ipilimumab will be administered on day 1 of each cycle every 3 weeks. In arm 3, ipilimumab should be started at least 2 weeks but no later than 120 days after surgical castration or the first dose of LHRH analogue. Patients should receive 2 doses of ipilimumab (6 weeks). It will be followed, 3 weeks later, by 3 cycles of docetaxel and by 2 additional doses of ipilimumab and 3 more cycles of docetaxel. Four weeks later, Nivolumab will be administered on day 1 every 2 weeks until a maximum of 24 doses (48 weeks)
DRUG	Nivolumab 10 MG/ML	Nivolumab will be administered every 2 weeks, until clinical progression or a maximum of 24 doses. Nivolumab should be started 4 weeks after the last dose of docetaxel, providing all the adverse effects have recovered, as if a new cycle of docetaxel were to be administered
DRUG	Docetaxel	Docetaxel should be given on day 1 every 21 days, for up to 6 cycles (1 cycle = 21 days). Docetaxel should be started within 7 working days from the date of randomization in the arm 1 and 2. In arm 3, docetaxel will be given 3 weeks after the last dose of the previous treatment, providing all the side effects are grade ≤1.
DRUG	ADT (androgen deprivation therapy)	Androgen deprivation therapy per the standard of care

Timeline

• Start date: 2019-02-11
• Primary completion: 2023-07-31
• Completion: 2024-12-31
• First posted: 2019-03-18
• Last updated: 2022-10-26

Locations

30 sites across 1 country: Spain