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ID05352178

Adding Short-Term Androgen Deprivation and Hormone Therapy to Metastasis-Directed Treatment for Oligorecurrent Hormone Sensitive Prostate Cancer to Improve Survival

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-03

873

Participants Needed

1

Research Sites

261 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating whether adding short-term androgen deprivation therapy ADT for either 1 month or 6 months, combined with an androgen receptor targeted therapy ARTA, to metastasis-directed therapy MDT can significantly extend the time patients with oligorecurrent hormone sensitive prostate cancer remain free from widespread metastases or metastatic castration-resistant prostate cancer. This phase 3 clinical trial explores improving outcomes by combining systemic treatments with targeted therapies in men whose cancer has returned but remains hormone sensitive. The study compares three treatment groups MDT alone, MDT plus 1 month of ADT using drugs such as gosereline, leuproreline, or triptoreline, and MDT plus 6 months of ADT combined with the ARTA drug enzalutamide. MDT involves stereotactic body radiotherapy SBRT or surgery to target metastatic lesions. Participants receive these treatments according to their assigned group, with dosing schedules including monthly or quarterly injections of ADT drugs and daily oral enzalutamide during the 6-month period. Participants will be involved in the study for up to 10 years, with follow-up assessments up to 5 years for outcomes like poly-metastatic free survival, metastatic castration-resistant prostate cancer free survival, biochemical and clinical progression-free survival, quality of life, and treatment toxicity. Researchers will monitor these outcomes alongside overall and cancer-specific survival to evaluate the long-term benefits and safety of adding systemic therapy to MDT in this patient group.

CONDITIONS

Brief Title

Metastasis-directed Therapy for Oligorecurrent Prostate Cancer

Research Team

K

Kato Rans, MD

G

Gert De Meerleer, MD, PhD

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