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

Radiotherapy Side Effect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02998619
• Other study ID #: BASEC 2016-01325
• Status: Completed
• Start date: December 2016
• Est. completion date: June 19, 2018

Study information

• Verified date: July 2018
• Source: Kantonsspital Graubuenden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 19, 2018
• Est. primary completion date: November 11, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymph Node Disease
• Prostatic Neoplasms
• Prostatic Neoplasms Benign
• Radiotherapy Side Effect

Intervention

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

Locations

Country	Name	City	State
Switzerland	Kantonsspital Graubuenden	Chur

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Graubuenden

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	PSA progession-free survival will be measured	through study completion, an average of 2 years
Secondary	Toxicity (CTCAE v4.03)	GI, GU Toxicities as well as Erectile Dysfunction will be measured	through study completion, an average of 2 years