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Completed

NCT Number: NCT03604211

SBRT 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.

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Key information

Conditions

Prostate Cancer Recurrent Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Lymph Node Metastases Lymphatic Metastasis Male Urogenital Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–85 year

Sex eligibility

Male

Study type

Observational

Primary location

Juergen Curschmann

Zurich, 8032, Switzerland

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyberknife Radiation Therapy

Radiation

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

Primary outcomes

  1. time to biochemical recurrence

    Time frame: 18 months

    time interval from SBRT until second PSA rise

Secondary outcomes

  1. biochemical response rate

    Time frame: 18 months

    reduction by at least 10% of the initial PSA value

  2. time interval between SBRT and ADT start

    Time frame: 18 months

    time interval between SBRT and ADT start

Sponsors and collaborators

Lead sponsor

Kantonsspital Graubuenden

Other

Collaborators

  • Swiss Cancer Institute

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2018
First posted
Jul 27, 2018
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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