Predictive Factors for the Benefit of Stereotactic Body Radiotherapy for Oligometastatic Lymph Node Recurrence in Prostate Cancer: a Single Institution Experience
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- time to biochemical recurrence
Study Overview
Brief Summary
Single-institution retrospective analysis for predictive factors of prostate cancer patients presenting with isolated or limited lymph node (LN) recurrence (1-3 lesions) on F-Ccholine PET-CT (CholPET) treated with SBRT between January 2010 and July 2015.
Detailed Description
Single-institution retrospective analysis of consecutive prostate cancer patients after definitive primary treatment, without local recurrence, presenting with isolated or limited lymph node (LN) recurrence (1-3 lesions) on F-Ccholine PET-CT (CholPET) treated with SBRT between January 2010 and July 2015.
Endpoints of interest are biochemical response rate (defined as a reduction by at least 10% of the initial PSA value), time to biochemical recurrence (TBR) (defined as the time interval from SBRT until second PSA rise), and time interval between SBRT and ADT start. Univariate analysis is used to identify prognostic factors.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •histologically proven diagnosis of prostate cancer
- •Radical prostatectomy (± salvage radiotherapy)
- •PSA relapse (defined by two consecutive rising PSA values >0.2 ug/l)
- •one to three lymphnodes positive on Choline-PET
- •no recurrence in prostatic bed on Choline-PET
- •WHO performance status of 0-1
- •no previous chemotherapy or ADT for prostate cancer.
Exclusion Criteria
- •primary treatment for prostate cancer by RT or brachytherapy
- •bone (M1b) metastases
- •visceral (M1c) metastases
- •any symptomatic nodal lesion
Outcomes
Primary Outcomes
time to biochemical recurrence
Time Frame: 18 months
time interval from SBRT until second PSA rise
Secondary Outcomes
- biochemical response rate(18 months)
- time interval between SBRT and ADT start(18 months)