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Completed

NCT Number: NCT01417676

DAPROCA Pelvic Lymph Node Irradiation to Prostate for High Risk Prostate Cancer: 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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Oncology, Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiation: pelvic lymph nodes with boost to prostate

Radiation

78(74)Gy/39(37) fractions to prostate, 56(55)GY /39(37) fractions to pelvic lymph nodes, 5 fractions per week.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aalborg University Hospital
  • Danish Center for Interventional Research in Radiation Oncology (CIRRO)
  • Herlev Hospital
  • Odense University Hospital
  • Rigshospitalet, Denmark
  • Vejle Hospital

Registry information

Official study title

Pelvic Lymph Node Irradiation With Simultaneous Integrated Boost to Prostate for High Risk Prostate Cancer Patients: A Phase I/II Study

Acronym: Propel

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Aug 16, 2011
Registry last updated
Jul 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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