DAPROCA Pelvic Lymph Node Irradiation to Prostate for Hig... | NCT01417676

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

NCT01417676

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Jul 1, 2020Actual

Enrollment

87Actual

Phase

Not Applicable

Conditions

Prostate Cancer

Interventions

Radiation: pelvic lymph nodes with boost to prostate

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011Actual

Primary Completion Date

May 2019Actual

Completion Date

May 2019Actual

First Submitted Date

Aug 15, 2011

First Submission Date that Met QC Criteria

Aug 15, 2011

First Posted Date

Aug 16, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2020

Last Update Posted Date

Jul 1, 2020Actual

Name	Class
Rigshospitalet, Denmark	OTHER
Herlev Hospital	OTHER
Odense University Hospital	OTHER
Vejle Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

87Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Radiation	Experimental		Radiation: Radiation: pelvic lymph nodes with boost to prostate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of late gastro-intestinal toxicity ≥ grade 2.	based on CTCAE v.4.0 og in-house questionnaire.	3 years and beyond

Secondary Outcomes

Measure	Description	Time Frame
survival		10 years
recurrence		10 years
Incidence of late genito-urinary toxicity ≥ grade 2.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lise N Bentzen, MD., Ph.D	Aarhus University Hospital, Daproca, CIRRO	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Oncology, Aarhus University Hospital		Aarhus		8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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.