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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
August 15, 2011
August 16, 2011
January 12, 2017
April 2011
December 2019   (Final data collection date for primary outcome measure)
Incidence of late gastro-intestinal toxicity ≥ grade 2. [ Time Frame: 3 years and beyond ]
based on CTCAE v.4.0 og in-house questionnaire.
  • Incidence of late gastro-intestinal toxicity ≥ grade 2. [ Time Frame: 3 years and beyond ]
    based on CTCAE v.4.0 og in-house questionnaire.
  • Incidence of late uro-genital toxicity ≥ grade 2 [ Time Frame: 3 years and beyond ]
Complete list of historical versions of study NCT01417676 on ClinicalTrials.gov Archive Site
  • 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
  • survival [ Time Frame: 10 years ]
  • recurrence [ Time Frame: 10 years ]
Not Provided
Not Provided
 
DAPROCA Pelvic Lymph Node Irradiation to Prostate for High Risk Prostate Cancer: Phase I/II Study
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.
Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
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.
Experimental: Radiation
Intervention: Radiation: Radiation: pelvic lymph nodes with boost to prostate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
December 2021
December 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01417676
CIRRO IP080210
No
Not Provided
Not Provided
University of Aarhus
University of Aarhus
  • Rigshospitalet, Denmark
  • Herlev Hospital
  • Odense University Hospital
  • Vejle Hospital
  • Aalborg Universitetshospital
  • Danish Center for Interventional Research in Radiation Oncology (CIRRO)
Principal Investigator: Lise N Bentzen, MD., Ph.D Aarhus University Hospital, Daproca, CIRRO
University of Aarhus
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP