NCT02998619

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 20, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2018

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

12 months

First QC Date

December 11, 2016

Last Update Submit

July 27, 2018

Conditions

Prostatic Neoplasms BenignRadiotherapy Side EffectLymph Node Disease

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    PSA progession-free survival will be measured

    through study completion, an average of 2 years

Secondary Outcomes (1)

  • Toxicity (CTCAE v4.03)

    through study completion, an average of 2 years

Study Arms (1)

Radiotherapy

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

Radiation: Radiotherapy

Interventions

RadiotherapyRADIATION

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

Radiotherapy

Eligibility Criteria

Age18 Years - 100 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Retrospective analysis of men irradiated for high risk prostate cancer including pelvic lymph nodes (L5/S1)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Graubuenden

Chur, 7000, Switzerland

Location

MeSH Terms

Conditions

Radiation Injuries

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Daniel R Zwahlen, MD, MBA

    Kantonsspital Graubuenden

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2016

First Posted

December 20, 2016

Study Start

December 1, 2016

Primary Completion

November 11, 2017

Study Completion

June 19, 2018

Last Updated

July 31, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)