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

• Sponsor: Kantonsspital Graubuenden (Other)
• Overall Status: Completed
• CT.gov ID: NCT02998619
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Duration (Months): 18.6
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms Benign; Radiotherapy Side Effect; Lymph Node Disease	Radiation: Radiotherapy

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 Design

• Study Type: Observational
• Actual Enrollment: 52 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Retrospektive Analyse Der Radiotherapie Des Pelvinen Lymphabflusses Beim Lokalisierten Prostatakarzinom Vom Hochrisikotyp Anhand Der Klinikdatenbank 2010-2016
• Study Start Date: Dec 1, 2016
• Actual Primary Completion Date: Nov 11, 2017
• Actual Study Completion Date: Jun 19, 2018

Arms and Interventions

Arm	Intervention/Treatment
Radiotherapy Radiation to prostate/seminal vesicles including pelvic lymph nodes Postoperative radiation to prostate bed including pelvic lymph nodes	Radiation: Radiotherapy; Radiation to prostate/seminal vesicles including pelvic lymph nodes Postoperative radiation to prostate bed including pelvic lymph nodes

Outcome Measures

Primary Outcome Measures

1. Progression-free survival [through study completion, an average of 2 years]

   PSA progession-free survival will be measured

Secondary Outcome Measures

1. Toxicity (CTCAE v4.03) [through study completion, an average of 2 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kantonsspital Graubuenden	Chur		Switzerland	7000

Sponsors and Collaborators

• Kantonsspital Graubuenden

Investigators

• Study Chair: Daniel R Zwahlen, MD, MBA, Kantonsspital Graubuenden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kantonsspital Graubuenden
• ClinicalTrials.gov Identifier: NCT02998619
• Other Study ID Numbers: BASEC 2016-01325
• First Posted: Dec 20, 2016
• Last Update Posted: Jul 31, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Jul 31, 2018