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

NCT ID: NCT03604211

Last Updated: 2018-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2018-07-31

Brief Summary

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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

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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.

Conditions

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Prostate Cancer Recurrent Prostate Cancer Lymph Node Metastases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Cyberknife Radiation Therapy

Stereotactic Radiotherapy of lymphnode recurrence after prostatectomy +/- salvage radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Swiss Cancer Institute

OTHER

Sponsor Role collaborator

Kantonsspital Graubuenden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel R Zwahlen, MD

Role: STUDY_DIRECTOR

Kantonsspital Graubuenden

Locations

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Juergen Curschmann

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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KGraubuenden

Identifier Type: -

Identifier Source: org_study_id

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