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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:
Collaborators:
Rigshospitalet, Denmark
Herlev Hospital
Odense University Hospital
Vejle Hospital
Aalborg Universityhospital
Danish Center for Interventional Research in Radiation Oncology (CIRRO)
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01417676
First received: August 15, 2011
Last updated: November 22, 2012
Last verified: November 2012
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    based on CTCAE v.4.0 og in-house questionnaire.


Secondary Outcome Measures:
  • survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • recurrence [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Incidence of late genito-urinary toxicity ≥ grade 2. [ Time Frame: 3 years and beyond ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 75 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Universityhospital
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

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01417676     History of Changes
Other Study ID Numbers: CIRRO IP080210
Study First Received: August 15, 2011
Last Updated: November 22, 2012
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

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

ClinicalTrials.gov processed this record on May 19, 2013