SBRT for Oligometastatic Lymph Node Recurrence in Prostate Cancer: a Single Institution Experience

Prostate Cancer Clinical Trial

Official title:

Predictive Factors for the Benefit of Stereotactic Body Radiotherapy for Oligometastatic Lymph Node Recurrence in Prostate Cancer: a Single Institution Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03604211
• Other study ID #: KGraubuenden
• Status: Completed
• Start date: January 2010
• Est. completion date: July 2018

Study information

• Verified date: August 2018
• Source: Kantonsspital Graubuenden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2018
• Est. primary completion date: July 2015
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymph Node Metastases
• Prostate Cancer
• Prostate Cancer Recurrent
• Prostatic Neoplasms
• Recurrence

Intervention

Radiation:
• Cyberknife Radiation Therapy
Stereotactic Radiotherapy of lymphnode recurrence after prostatectomy +/- salvage radiotherapy

Locations

Country	Name	City	State
Switzerland	Juergen Curschmann	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Kantonsspital Graubuenden	Swiss Group for Clinical Cancer Research

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to biochemical recurrence	time interval from SBRT until second PSA rise	18 months
Secondary	biochemical response rate	reduction by at least 10% of the initial PSA value	18 months
Secondary	time interval between SBRT and ADT start	time interval between SBRT and ADT start	18 months