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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Radiation: pelvic lymph nodes with boost to prostate
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, locally advanced, lymph node positive, radiation therapy, morbidity, early morbidity, late morbidity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Dept. of Oncology, Aarhus University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiation

Arm Description

Outcomes

Primary Outcome Measures

Incidence of late gastro-intestinal toxicity ≥ grade 2.
based on CTCAE v.4.0 og in-house questionnaire.

Secondary Outcome Measures

survival
recurrence
Incidence of late genito-urinary toxicity ≥ grade 2.
Based on CTCAE vers. 4.0 and in-house questionnaire

Full Information

First Posted
August 15, 2011
Last Updated
June 29, 2020
Sponsor
University of Aarhus
Collaborators
Rigshospitalet, Denmark, Herlev Hospital, Odense University Hospital, Vejle Hospital, Aalborg University Hospital, Danish Center for Interventional Research in Radiation Oncology (CIRRO)
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1. Study Identification

Unique Protocol Identification Number
NCT01417676
Brief Title
DAPROCA Pelvic Lymph Node Irradiation to Prostate for High Risk Prostate Cancer: Phase I/II Study
Acronym
Propel
Official Title
Pelvic Lymph Node Irradiation With Simultaneous Integrated Boost to Prostate for High Risk Prostate Cancer Patients: A Phase I/II Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 2011 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Rigshospitalet, Denmark, Herlev Hospital, Odense University Hospital, Vejle Hospital, Aalborg University Hospital, Danish Center for Interventional Research in Radiation Oncology (CIRRO)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, locally advanced, lymph node positive, radiation therapy, morbidity, early morbidity, late morbidity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiation
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Radiation: pelvic lymph nodes with boost to prostate
Intervention Description
78(74)Gy/39(37) fractions to prostate, 56(55)GY /39(37) fractions to pelvic lymph nodes, 5 fractions per week.
Primary Outcome Measure Information:
Title
Incidence of late gastro-intestinal toxicity ≥ grade 2.
Description
based on CTCAE v.4.0 og in-house questionnaire.
Time Frame
3 years and beyond
Secondary Outcome Measure Information:
Title
survival
Time Frame
10 years
Title
recurrence
Time Frame
10 years
Title
Incidence of late genito-urinary toxicity ≥ grade 2.
Description
Based on CTCAE vers. 4.0 and in-house questionnaire
Time Frame
3 years and beyond

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lise N Bentzen, MD., Ph.D
Organizational Affiliation
Aarhus University Hospital, Daproca, CIRRO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Oncology, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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