We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01417676
First Posted: August 16, 2011
Last Update Posted: January 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Rigshospitalet, Denmark
Herlev Hospital
Odense University Hospital
Vejle Hospital
Aalborg Universitetshospital
Danish Center for Interventional Research in Radiation Oncology (CIRRO)
Information provided by (Responsible Party):
University of Aarhus
  Purpose
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.

Condition Intervention Phase
Prostate Cancer Radiation: Radiation: pelvic lymph nodes with boost to prostate Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pelvic Lymph Node Irradiation With Simultaneous Integrated Boost to Prostate for High Risk Prostate Cancer Patients: A Phase I/II Study

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

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


Secondary Outcome Measures:
  • survival [ Time Frame: 10 years ]
  • recurrence [ Time Frame: 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


Estimated Enrollment: 80
Study Start Date: April 2011
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01417676


Locations
Denmark
Dept. of Oncology, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Rigshospitalet, Denmark
Herlev Hospital
Odense University Hospital
Vejle Hospital
Aalborg Universitetshospital
Danish Center for Interventional Research in Radiation Oncology (CIRRO)
Investigators
Principal Investigator: Lise N Bentzen, MD., Ph.D Aarhus University Hospital, Daproca, CIRRO
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01417676     History of Changes
Other Study ID Numbers: CIRRO IP080210
First Submitted: August 15, 2011
First Posted: August 16, 2011
Last Update Posted: January 12, 2017
Last Verified: January 2017

Keywords provided by University of Aarhus:
prostate cancer
locally advanced
lymph node positive
radiation therapy
morbidity
early morbidity
late morbidity

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases