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

NCT01417676 | Completed

• 1 other identifier: CIRRO IP080210
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; locally advanced; lymph node positive; radiation therapy; morbidity; early morbidity; late morbidity

Outcome Measures

Primary Outcomes (1)

• Incidence of late gastro-intestinal toxicity ≥ grade 2.

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

  3 years and beyond

Secondary Outcomes (3)

• survival

  10 years

• recurrence

  10 years

• Incidence of late genito-urinary toxicity ≥ grade 2.

  3 years and beyond

Study Arms (1)

Radiation

EXPERIMENTAL

Radiation: Radiation: pelvic lymph nodes with boost to prostate

Interventions

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.

Radiation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pelvic co-morbidity such as Crohns disease or ulcerative colitis
• uncontrolled heart or lung morbidity
• prior radiation treatment of pelvic region
• age \> 75 years

Sponsors & Collaborators

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

Study Sites (1)

Dept. of Oncology, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Lise N Bentzen, MD., Ph.D

  Aarhus University Hospital, Daproca, CIRRO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients are allocated for lymph node irradiation, either up front combined with prostate irradiation or lymph node irradiation after primary lymph adenectomy after combined with prostate irradiation.

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: August 16, 2011
• Study Start: April 1, 2011
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: July 1, 2020

Record last verified: 2020-06

Locations

DK (1)