Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-02-25 @ 8:30 PM
Study NCT ID:
NCT03796767
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-17
First Post:
2019-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Salvage Oligometastasectomy and Radiation Therapy in Recurrent Prostate Cancer
Sponsor:
University of Utah
Organization:
Study Overview
Official Title:
Salvage Oligometastasectomy and Radiation Therapy in Recurrent Prostate Cancer (SOAR)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOAR
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2018-03418 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |