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

NCT ID: NCT01417676

Last Updated: 2020-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2019-05-31

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiation

Group Type EXPERIMENTAL

Radiation: pelvic lymph nodes with boost to prostate

Intervention Type RADIATION

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

Interventions

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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.

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Herlev Hospital

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role collaborator

Vejle Hospital

OTHER

Sponsor Role collaborator

Aalborg University Hospital

OTHER

Sponsor Role collaborator

Danish Center for Interventional Research in Radiation Oncology (CIRRO)

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lise N Bentzen, MD., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital, Daproca, CIRRO

Locations

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Dept. of Oncology, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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CIRRO IP080210

Identifier Type: -

Identifier Source: org_study_id

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