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

Prostate Cancer Clinical Trial

— Propel  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01417676
• Other study ID #: CIRRO IP080210
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: May 2019

Study information

• Verified date: June 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Denmark	Dept. of Oncology, Aarhus University Hospital	Aarhus

Sponsors (7)

Lead Sponsor	Collaborator
University of Aarhus	Aalborg University Hospital, Danish Center for Interventional Research in Radiation Oncology (CIRRO), Herlev Hospital, Odense University Hospital, Rigshospitalet, Denmark, Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of late gastro-intestinal toxicity = grade 2.	based on CTCAE v.4.0 og in-house questionnaire.	3 years and beyond
Secondary	survival		10 years
Secondary	recurrence		10 years
Secondary	Incidence of late genito-urinary toxicity = grade 2.	Based on CTCAE vers. 4.0 and in-house questionnaire	3 years and beyond