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

Not Applicable

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT01417676
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-08-15
• Study First Submitted QC: 2011-08-15
• Study First Posted: 2011-08-16
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-29
• Last Update Posted: 2020-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 87

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of late gastro-intestinal toxicity ≥ grade 2.	3 years and beyond	based on CTCAE v.4.0 og in-house questionnaire.

Secondary Outcome Measures

Name	Time	Method
Incidence of late genito-urinary toxicity ≥ grade 2.	3 years and beyond	Based on CTCAE vers. 4.0 and in-house questionnaire
recurrence	10 years
survival	10 years

Trial Locations

Locations (1)

Dept. of Oncology, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark