NCT03796767

Salvage Oligometastasectomy and Radiation Therapy in Recurrent Prostate Cancer

Salvage Oligometastasectomy and Radiation Therapy in Recurrent Prostate Cancer (SOAR)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well surgery and radiation therapy work in treating patients with prostate cancer that has come back or spread to other parts of the body. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Surgical procedures, such as oligometastasectomy, may remove tumor cells that have spread to other parts of the body. Surgery and radiation therapy may work better in treating patients with prostate cancer that has come back or spread to other parts of the body.

Detailed description

PRIMARY OBJECTIVES: I. To assess response to treatment of oligometastatic disease. SECONDARY OBJECTIVES: I. To assess additional measurements of response to treatment of oligometastatic disease. II. To assess prostate-specific antigen (PSA) progression free-survival following treatment of oligometastatic disease. III. To assess time to disease recurrence following treatment of oligometastatic disease. IV. To assess time to initiation of antiandrogen therapy (ADT) for metastatic prostate cancer following treatment of oligometastatic disease. V. To assess the rate of undetectable PSA following treatment of oligometastatic disease in subjects who have previously undergone prostatectomy. VI. To assess safety. VII. To assess the impact of study treatment on change in quality of life over three years.

Conditions

• Recurrent Prostate Carcinoma
• Metastatic Malignant Neoplasm in the Bone
• Metastatic Malignant Neoplasm in the Lymph Nodes
• Oligometastasis
• Prostate Adenocarcinoma
• PSA Failure

Interventions

Type	Name	Description
RADIATION	Hypofractionated Radiation Therapy	Undergo hypofractionated radiation therapy
RADIATION	Intensity-Modulated Radiation Therapy	Undergo IMRT
PROCEDURE	Metastasectomy	Undergo salvage oligometastasectomy
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
RADIATION	Stereotactic Body Radiation Therapy	Undergo SBRT

Timeline

• Start date: 2019-09-09
• Primary completion: 2024-02-13
• Completion: 2026-06-30
• First posted: 2019-01-08
• Last updated: 2026-01-28
• Results posted: 2025-10-20

Locations

1 site across 1 country: United States