Local Ablative Therapy For Hormone Sensitive Oligometastatic Prostate Cancer

Official Title

A Randomized Phase III Trial of Local Ablative Therapy For Hormone Sensitive Oligometastatic Prostate Cancer [PLATON]

Summary:

The purpose of this study is to compare the effects of ablative therapy (radiation or surgery) to all sites of disease combined with standard treatments on prostate cancer, compared to the standard or usual treatments used to treat this disease.

Trial Description

Primary Outcome:

• Failure-free Survival

Secondary Outcome:

• Radiographic Progression-free Survival
• Incidence of new metastases as first event
• Overall Survival
• Ablative treatment related adverse events (>/= grade 3) using CTCAE v5.0
• Quality of Life measured by EORTC QLQ-C30
• Quality of Life measured by Bone Metastases module (BM22)
• Quality of Life measured by prostate (PR25) questionnaire module
• Economic analysis measured by EQ-5D-5L
• Economic analysis by determining an incremental cost-effectiveness ratio reported as a difference in cost per FFS-year between the 2 arms

The standard or usual treatment for this disease is systemic therapy, which includes androgen deprivation therapy (ADT) with or without chemotherapy or hormone therapy. Additionally, for some patients with specific disease features, standard treatment may also include ablative treatment (radiation or surgery) of the prostate gland if this was not completed prior to enrolling into this study. Ablative Therapy is a procedure used to destroy cancer cells and tissue. In this study Stereotactic Body Radiation Therapy (SBRT) or surgery will be used to destroy prostate cancer metastases. It is not clear if ablative therapy (SBRT or surgery) to all sites of disease used in combination with standard systemic therapy can offer better results than standard treatment alone.

View this trial on ClinicalTrials.gov