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

University of Aarhus87 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

Radiation: pelvic lymph nodes with boost to prostateRADIATION

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Dept. of Oncology, Aarhus University Hospital

Aarhus, Denmark

Outcomes

Primary Outcomes

Incidence of late gastro-intestinal toxicity ≥ grade 2.

based on CTCAE v.4.0 og in-house questionnaire.

Time frame: 3 years and beyond

Secondary Outcomes

survival

Time frame: 10 years

recurrence

Time frame: 10 years

Incidence of late genito-urinary toxicity ≥ grade 2.

Based on CTCAE vers. 4.0 and in-house questionnaire

Time frame: 3 years and beyond

Data from ClinicalTrials.gov

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