DAPROCA Pelvic Lymph Node Irradiation to Prostate for High Risk Prostate Cancer: Phase I/II Study (Propel)

June 29, 2020 updated by: University of Aarhus

Pelvic Lymph Node Irradiation With Simultaneous Integrated Boost to Prostate for High Risk Prostate Cancer Patients: A Phase I/II Study

This is a prospective, open label 1 arm study, multicentre, Phase I/II clinical safety study. The trial is designed to gain initial safety and efficacy data on pelvic lymph node radiation with simultaneous integrated boost to prostate in high risk prostate cancer patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Dept. of Oncology, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • adenocarcinoma
  • T3 tumor and either Gleason 8-10 and PSA ≤ 70,or PSA ≥ 30 and PSA ≤ 70, or T1-T3 and PSA ≤ 70 and N1
  • no distant metastases

Exclusion Criteria:

  • pelvic co-morbidity such as Crohns disease or ulcerative colitis
  • uncontrolled heart or lung morbidity
  • prior radiation treatment of pelvic region
  • age > 75 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Radiation
Radiation: Radiation: pelvic lymph nodes with boost to prostate
78(74)Gy/39(37) fractions to prostate, 56(55)GY /39(37) fractions to pelvic lymph nodes, 5 fractions per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of late gastro-intestinal toxicity ≥ grade 2.
Time Frame: 3 years and beyond
based on CTCAE v.4.0 og in-house questionnaire.
3 years and beyond

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival
Time Frame: 10 years
10 years
recurrence
Time Frame: 10 years
10 years
Incidence of late genito-urinary toxicity ≥ grade 2.
Time Frame: 3 years and beyond
Based on CTCAE vers. 4.0 and in-house questionnaire
3 years and beyond

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Odense University Hospital
Rigshospitalet, Denmark
Herlev Hospital
Vejle Hospital
Aalborg University Hospital
Danish Center for Interventional Research in Radiation Oncology (CIRRO)

Investigators

  • Principal Investigator: Lise N Bentzen, MD., Ph.D, Aarhus University Hospital, Daproca, CIRRO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2011

Primary Completion (ACTUAL)

May 1, 2019

Study Completion (ACTUAL)

May 1, 2019

Study Registration Dates

First Submitted

August 15, 2011

First Submitted That Met QC Criteria

August 15, 2011

First Posted (ESTIMATE)

August 16, 2011

Study Record Updates

Last Update Posted (ACTUAL)

July 1, 2020

Last Update Submitted That Met QC Criteria

June 29, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIRRO IP080210

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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