This trial is active, not recruiting.

Condition prostate cancer
Treatment radiation: pelvic lymph nodes with boost to prostate
Phase phase 1/phase 2
Sponsor University of Aarhus
Collaborator Rigshospitalet, Denmark
Start date April 2011
End date December 2019
Trial size 80 participants
Trial identifier NCT01417676, CIRRO IP080210


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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 Outcomes

Incidence of late gastro-intestinal toxicity ≥ grade 2.
time frame: 3 years and beyond

Secondary Outcomes

time frame: 10 years
time frame: 10 years
Incidence of late genito-urinary toxicity ≥ grade 2.
time frame: 3 years and beyond

Eligibility Criteria

Male participants from 18 years up to 75 years old.

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

Additional Information

Official title Pelvic Lymph Node Irradiation With Simultaneous Integrated Boost to Prostate for High Risk Prostate Cancer Patients: A Phase I/II Study
Principal investigator Lise N Bentzen, MD., Ph.D
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by University of Aarhus.