NCT01787630

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
81

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

November 4, 2016

Status Verified

November 1, 2016

Enrollment Period

6.2 years

First QC Date

February 6, 2013

Last Update Submit

November 3, 2016

Conditions

Prostatic Cancer

Keywords

Prostatic cancerRadiotherapyHyaluronic acid

Outcome Measures

Primary Outcomes (1)

  • Remaining volume of HA

    Measurement on the remaining volume of HA by MRI

    24 month after end of radiotherapy

Secondary Outcomes (1)

  • Quality of life

    24 month after end of radiotherapy

Study Arms (1)

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

Hyaluronic acidDEVICE

Injection in connection with ultrasound

Also known as: NASHA Spacer Gel
Hyaluronic acid

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of oncology, Kalmar Hospital

Kalmar, SE-39244, Sweden

Location

Department of oncilogy, Sundsvall Hospital

Sundsvall, SE-851 86, Sweden

Location

Department of oncology, University Hospital

Umeå, SE-901 85, Sweden

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Anders Widmark, Prof MD

    Umea university, dept of oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

February 6, 2013

First Posted

February 8, 2013

Study Start

January 1, 2010

Primary Completion

March 1, 2016

Study Completion

March 1, 2021

Last Updated

November 4, 2016

Record last verified: 2016-11

Locations

SE(3)