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Prostate CancerPhase 3NCT01538628

SpaceOAR System Pivotal Study

A Phase 3 study testing SpaceOAR System in people with Prostate Cancer, run by Boston Scientific Corporation at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Evaluate the safety of the SpaceOAR System when the hydrogel is injected between the rectum and prostate in men undergoing radiation therapy (IG-IMRT) Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
SpaceOAR System
Could I receive a placebo?
No, everyone receives an active treatment
How many people
222 participants
Where
20 sitesUnited States
Study dates
Jan 2012to Jul 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects greater than 18 years old
  • Subjects must have pathologically confirmed invasive adenocarcinoma of the prostate and must be planning to undergo IMRT
  • Subjects must have clinical stage T1 or T2 as determined from a biopsy taken within 6 months of the baseline/screening visit with Gleason Score less than or equal to 7
  • Subjects Screening/Baseline laboratory testing must meet the following laboratory value criteria: PSA less than or equal to 20 ng/mL,hematocrit greater than 30%,serum creatinine less than 2.0 mg/dl, serum AST and ALT less than 2.5 times upper limit of institution normal, and serum bilirubin less than 2.0 mg/dl
  • Subject or authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site

Who cannot join

  • Prostate greater than 80cc documented within 3 months preceding the Screening/Baseline visit
  • Subjects with extracapsular extension of the prostate cancer, with greater than 50% of the number of biopsy cores positive for cancer, metastatic disease, other ongoing cancers which will be treated during the study, or subjects for whom pelvic lymph node radiotherapy is planned
  • Subjects with any prior invasive malignancy (except non-melanomatous skin cancer) unless the subject has been disease free for a minimum of 5 years.
  • Subjects who are indicated for androgen deprivation therapy or who have been treated with androgen therapy within the prior 3 months.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Emory University

    Atlanta, Georgia, 30322

  • Johns Hopkins University Department of Radiation Oncology and Molecular Radiation Sciences

    Baltimore, Maryland, 21231

  • Lakewood Ranch Oncology Center/21st Century Oncology

    Bradenton, Florida, 34202

  • Urological Surgeons of Northern California

    Campbell, California, 95008

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • The Urology Center of Colorado

    Denver, Colorado, 80211

  • Western New York Urology Associates, LLC and D/B/A Cancer Care of WNY

    Erie, Niagara, and Chautauqua County, New York, 14267

  • 21st Century Oncology

    Fort Myers, Florida, 33907

  • CentraState Medical Center

    Freehold, New Jersey, 07728

  • Advanced Radiation Centers of New York

    Lake Success, New York, 11042

  • 21st Century Oncology

    Myrtle Beach, South Carolina, 29577

  • Chesapeake Urology Associates, Chesapeake Urology Research Associates (The Prostate Center)

    Owings Mills, Maryland, 21117

  • Foundation for Cancer Research and Education

    Phoenix, Arizona, 85013

  • Peninsula Cancer Center

    Poulsbo, Washington, 98370

  • Northern Nevada Radiation Oncology

    Reno, Nevada, 89521

  • University of Rochester

    Rochester, New York, 14642

  • Radiological Associates of Sacramento

    Sacramento, California, 95815

  • Oregon Urology Institute

    Springfield, Oregon, 97477

  • Associated Medical Professionals of NY

    Syracuse, New York, 13210

  • Upstate Medical University

    Syracuse, New York, 13210

Other trials in United States

About this study

Official title: Evaluation of SpaceOAR™ System When Used to Create Space Between the Rectum and Prostate in Men Undergoing IG-IMRT for Localized Stage T1-T2 Prostate Cancer: A Randomized, Multicenter, Parallel Arm Controlled Clinical Study

Evaluate the safety of the SpaceOAR System when the hydrogel is injected between the rectum and prostate in men undergoing radiation therapy (IG-IMRT)

Read the detailed description

The purpose of this study is to evaluate the safety of the SpaceOAR System when the hydrogel is injected between the rectum and prostate in men undergoing radiation therapy (IG-IMRT) and to evaluate whether use of the SpaceOAR hydrogel results in a reduction of radiation exposure to the anterior rectum.

Conditions
Prostate Cancer
Being tested
SpaceOAR System
Keywords
Prostate cancer, Spacer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SpaceOAR SystemDevice

    Fiducial marker placement followed by randomization to treatment group, i.e., 10mL SpaceOAR hydrogel injection, or control group, i.e., no injection of SpaceOAR hydrogel.

Study groups in NCT01538628
Study groupRoleWhat they receive
SpaceOARExperimentalMen meeting the study eligibility criteria will be scheduled for fiducial marker placement using a transperineal approach with ultrasound guidance. Following successful fiducial marker placement, subjects will be randomized (2:1) to the treatment group or control group. Subjects randomized to the treatment group will undergo placement of 10 mL of SpaceOAR hydrogel
Receives: Device: SpaceOAR System
ControlNo interventionMen meeting the study eligibility criteria will be scheduled for fiducial marker placement using a transperineal approach with ultrasound guidance. Following successful fiducial marker placement, subjects will be randomized (2:1) to the treatment group or control group. Subjects randomized to the control group will not receive injection of the SpaceOAR hydrogel.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects Achieving a Reduction of 25% or Greater in Percent Volume of the Rectum Receiving at Least 70 Gy Measured From CT Scans Acquired Pre and Post SpaceOAR Hydrogel Injection

    Measurements calculated and documented by the Core Lab. Measurements performed with the Core Lab blinded to subject identification. Results based on the Core Lab computation are considered as primary.

    Measured: 3 months post index procedure

  2. Percentage of Subjects Experiencing Grade 1 or Greater Rectal or Procedure Adverse Events Post Index Procedure

    The primary safety endpoint was the occurrence of Grade 1 or greater rectal adverse events or procedure adverse events in the 6 months following the Index Procedure. The numbers reflect the percent of subjects in each arm/group that experienced grade 1 or greater rectal or procedure adverse events post index procedure.

    Measured: 6 months post index procedure

Secondary outcomes (5)

  1. Percentage of Subjects Experiencing Grade 2 or Greater Rectal or Procedure Adverse Events in the 6 Months Following the Index Procedure

    The numbers reflect the percent of subjects in each arm/group that experienced grade 2 or greater rectal or procedure adverse events post index procedure.

    Measured: 6 months post index procedure

  2. Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure

    Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive survey instrument designed to assesses the disease-specific aspects of prostate cancer and its therapies and comprises four domains. Scores for each domain (urinary, sexual, bowel, hormonal) range from 0-100, with higher scores indicating improved quality of life. Scores are reported as mean change from baseline at each time point.

    Measured: 3 months, 6 months, 12 months, 15 months

  3. Percentage of Subjects Requiring at Least One Medication Change for Mitigation of Rectal or Urinary Symptoms or for Procedure-related Events in the 6 Months Following the Index Procedure

    The numbers reflect the percent of subjects in each arm/group that required at least one medication change to treat rectal or urinary symptoms in the 6 months post index procedure.

    Measured: 6 months post procedure

  4. Number of SpaceOAR Subjects Experiencing a Procedure-Related Adverse Event (AE) Prior to Initiation of Radiation Therapy

    An event was classified as a Procedure AE if it occurred during during and immediately after the Index Procedure or was deemed to be associated with the Index Procedure by the Clinical Events Committee (CEC). Per protocol subjects were to begin intensity modulated radiation therapy within 21 days following fiducial marker and/or SpaceOAR placement.

    Measured: 21 days post index procedure, prior to initiation of radiation therapy

  5. Number of Subjects Experiencing a Delay in Radiation Therapy Associated With a Procedure or Device-Related Adverse Event

    All subjects begin Intensity Modulated Radiation Therapy (IMRT) within 21 days following index procedure (Fiducial Marker Placement with or without SpaceOAR Hydrogel Injection).

    Measured: 21 days post index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
222 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01538628
Sponsor's protocol ID
AGX-11-001-US
Status last verified
Feb 2021
First submitted
21 Feb 2012
Last updated
19 Mar 2021
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SpaceOAR System in people with Prostate Cancer, run by Boston Scientific Corporation at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects Achieving a Reduction of 25% or Greater in Percent Volume of the Rectum Receiving at Least 70 Gy Measured From CT Scans Acquired Pre and Post SpaceOAR Hydrogel Injection (time frame: 3 months post index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01538628.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.

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