To Evaluate the Technique and Effects of Separating the P... | NCT01787630

Studies
To Evaluate the Technique and Effects of Separating the Prostate and Rectum With Hyaluronic Acid During Radiotherapy

NCT01787630

Sponsor

Anders Widmark

Status

Unknown status

Last Update Posted

Nov 4, 2016Estimated

Enrollment

81Actual

Phase

Phase 2Phase 3

Conditions

Prostatic Cancer

Interventions

Hyaluronic acid

Countries

Sweden

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

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2021Estimated

First Submitted Date

Feb 6, 2013

First Submission Date that Met QC Criteria

Feb 6, 2013

First Posted Date

Feb 8, 2013Estimated

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

Nov 3, 2016

Last Update Posted Date

Nov 4, 2016Estimated

Name	Class
University Hospital, Umeå	OTHER

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

The dominating problem after local radiotherapy of prostate cancer is rectal toxicity. If the rectum could be completely moved out of the treated volume, a substantial decrease of rectal toxicity seems reasonable. In this study we will develop and evaluate a new transrectal injection technique where hyaluronic acid (HA) is injected in the space between the prostate and the rectum prior to external beam radiotherapy to increase the physical distance between prostate and rectum.

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

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

81Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hyaluronic acid	Experimental	Hyaluronic acid will be injected in the space between the prostate and rectum prior to radiotherapy to perform a dorsal movement of rectum.	Device: Hyaluronic acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hyaluronic acid	Device	Injection in connection with ultrasound	Hyaluronic acid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Remaining volume of HA	Measurement on the remaining volume of HA by MRI	24 month after end of radiotherapy

Secondary Outcomes

Measure	Description	Time Frame
Quality of life	Patient evaluation with questionnaires regarding Quality of Life and side effects after radiotherapy	24 month after end of radiotherapy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically verified prostatic cancer
Low or intermediate risk prostatic cancer
Lymph node negative
Suitable for radiotherapy

Exclusion Criteria:

Earlier treatment for prostatic cancer
Unable to co-operate or suffering from any other form of disease that would interfere with the planned treatment

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
Anders Widmark, Prof MD	Umea university, dept of oncology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of oncology, Kalmar Hospital		Kalmar		SE-39244	Sweden
Department of oncilogy, Sundsvall Hospital

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