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NCT Number: NCT02998619

Radiotherapy of Pelvic Lymph Nodes in High Risk Prostate Cancer - A Retrospective Analysis

Men with high risk prostate cancer who underwent radiotherapy of the prostate/seminal vesicles or underwent postoperative radiotherapy including pelvic lymph nodes between 2010 and 2016 are analyzed retrospectively. The aims are to estimate progression-free survival as well as toxicity according to CTCAE v4.03.

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Key information

Conditions

Prostatic Neoplasms Benign Lymph Node Disease Radiation Injuries Radiotherapy Side Effect Wounds and Injuries

Age range

18 year–100 year

Sex eligibility

Male

Study type

Observational

Primary location

Kantonsspital Graubuenden

Chur, 7000, Switzerland

About this study

Collection of data and retrospective analysis of patients with high risk prostate cancer treated with radiotherapy to pelvic lymph nodes.

What influence has irradiation of pelvic lymph nodes on patients with high risk prostate cancer in terms of progression free survival and toxicity. How does this influence side effects with respect to gastrointestinal (proctitis, abdominal pain, diarrhea) and genitourinary (cystitis, urinary disorders) toxicities (CTCAE v4.03)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men with high risk prostate cancer treated with radiotherapy to prostate/seminal vesicles or postoperative radiotherapy and pelvic lymph nodes at the Kantonssptial Graubuenden, Department of Radiation Oncology between 2010 and 2016

Exclusion criteria

  • Men with prostate cancer other than high risk disease and no radiotherapy to pelvic lymph nodes

Treatment and study plan

Radiotherapy

Radiation

Radiation to prostate/seminal vesicles including pelvic lymph nodes Postoperative radiation to prostate bed including pelvic lymph nodes

Primary outcomes

  1. Progression-free survival

    Time frame: through study completion, an average of 2 years

    PSA progession-free survival will be measured

Secondary outcomes

  1. Toxicity (CTCAE v4.03)

    Time frame: through study completion, an average of 2 years

    GI, GU Toxicities as well as Erectile Dysfunction will be measured

Sponsors and collaborators

Lead sponsor

Kantonsspital Graubuenden

Other

Registry information

Official study title

Retrospektive Analyse Der Radiotherapie Des Pelvinen Lymphabflusses Beim Lokalisierten Prostatakarzinom Vom Hochrisikotyp Anhand Der Klinikdatenbank 2010-2016

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Dec 20, 2016
Registry last updated
Jul 31, 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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