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

Completed

• Conditions: Lymph Node Disease; Radiotherapy Side Effect; Prostatic Neoplasms Benign
• Interventions: Radiation: Radiotherapy

• Registration Number: NCT02998619
• Lead Sponsor: Kantonsspital Graubuenden

Brief Summary

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.

Detailed Description

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)

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-11
• Study First Submitted QC: 2016-12-16
• Study First Posted: 2016-12-20
• Primary Completion: 2017-11-11
• Study Completion: 2018-06-19
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-27
• Last Update Posted: 2018-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 52

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Radiotherapy	Radiotherapy	Radiation to prostate/seminal vesicles including pelvic lymph nodes Postoperative radiation to prostate bed including pelvic lymph nodes

Primary Outcome Measures

Name	Time	Method
Progression-free survival	through study completion, an average of 2 years	PSA progession-free survival will be measured

Secondary Outcome Measures

Name	Time	Method
Toxicity (CTCAE v4.03)	through study completion, an average of 2 years	GI, GU Toxicities as well as Erectile Dysfunction will be measured

Trial Locations

Locations (1)

Kantonsspital Graubuenden; 🇨🇭 Chur, Switzerland