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

August 15, 2018 updated by: Kantonsspital Graubuenden

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8032
        • Juergen Curschmann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

single-Institution cohort of male patients 18-85 years of age, with recurrent prostate cancer after radical prostatectomy in 1-3 lymphnodes, prospectively registered in a local institutional database

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to biochemical recurrence
Time Frame: 18 months
time interval from SBRT until second PSA rise
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
biochemical response rate
Time Frame: 18 months
reduction by at least 10% of the initial PSA value
18 months
time interval between SBRT and ADT start
Time Frame: 18 months
time interval between SBRT and ADT start
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kantonsspital Graubuenden

Collaborators

Swiss Group for Clinical Cancer Research

Investigators

  • Study Director: Daniel R Zwahlen, MD, Kantonsspital Graubuenden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2010

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

July 1, 2018

Study Registration Dates

First Submitted

July 19, 2018

First Submitted That Met QC Criteria

July 26, 2018

First Posted (ACTUAL)

July 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 2018

Last Update Submitted That Met QC Criteria

August 15, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KGraubuenden

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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