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

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.
 
ClinicalTrials.gov Identifier: NCT01417676
Recruitment Status : Completed
First Posted : August 16, 2011
Last Update Posted : July 1, 2020
Sponsor:
Collaborators:
Rigshospitalet, Denmark
Herlev Hospital
Odense University Hospital
Vejle Hospital
Aalborg University Hospital
Danish Center for Interventional Research in Radiation Oncology (CIRRO)
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Radiation: Radiation: pelvic lymph nodes with boost to prostate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Patients are allocated for lymph node irradiation, either up front combined with prostate irradiation or lymph node irradiation after primary lymph adenectomy after combined with prostate irradiation.
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
Actual Study Start Date : April 2011
Actual Primary Completion Date : May 2019
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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.




Primary Outcome Measures :
  1. 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 :
  1. survival [ Time Frame: 10 years ]
  2. recurrence [ Time Frame: 10 years ]
  3. Incidence of late genito-urinary toxicity ≥ grade 2. [ Time Frame: 3 years and beyond ]
    Based on CTCAE vers. 4.0 and in-house questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

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
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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 University Hospital
Danish Center for Interventional Research in Radiation Oncology (CIRRO)
Investigators
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Principal Investigator: Lise N Bentzen, MD., Ph.D Aarhus University Hospital, Daproca, CIRRO
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01417676    
Other Study ID Numbers: CIRRO IP080210
First Posted: August 16, 2011    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Keywords provided by University of Aarhus:
prostate cancer
locally advanced
lymph node positive
radiation therapy
morbidity
early morbidity
late morbidity
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases