Prostate Cancer Clinical Trial
— SABREOfficial title:
Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy
NCT number | NCT04905069 |
Other study ID # | U0702 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | December 21, 2021 |
Est. completion date | April 2030 |
To demonstrate the effectiveness of the SpaceOAR Vue System in reducing late gastrointestinal (GI) toxicity in subjects undergoing Stereotactic Body Radiotherapy (SBRT) to treat prostate cancer.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | April 2030 |
Est. primary completion date | April 2027 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years old. - Subjects must have pathologically confirmed (by routine hematoxylin and eosin (H&E) staining) invasive adenocarcinoma of the prostate and been planning to undergo SBRT. - Subjects must have intermediate risk prostate cancer as defined by the presence of one or more of the following: - Clinical Stage T2b - T2c (AJCC 6th edition) tumor - Gleason Score 7 as determined from a biopsy taken within 9 months preceding Enrollment (randomization) - Demonstrated blood PSA levels 10-20 ng/ml as measured within 6 months preceding Enrollment (randomization) and prior to commencing androgen deprivation therapy (ADT) - Subject or authorized representative was informed of the nature of the study and provided written informed consent, approved by the appropriate Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site. Exclusion Criteria: - Prostate >80 cc documented within 9 months preceding Enrollment (randomization) - Clinical stage T3 or T4 (AJCC 6th edition) tumor - Blood PSA level >20 ng/ml as measured within 6 months preceding Enrollment (randomization) and prior to commencing androgen deprivation therapy (ADT) - Gleason Score = 8 as determined from a biopsy taken within 9 months preceding Enrollment (randomization) - Subjects who had MRI evidence of gross posterior extracapsular extension (ECE) of the prostate cancer. (Note: MRI should be from within 9 months preceding Enrollment (randomization). If MRI is contraindicated, a digital rectal exam may be performed to confirm the absence of gross posterior ECE) - Subjects who had metastatic disease, other ongoing cancers which were treated during the study or subjects for whom pelvic lymph node radiotherapy was planned. - Subjects with any prior invasive malignancy (except non-melanomatous skin cancer) unless the subject had been disease free for a minimum of 3 years. - History of prostatectomy, transurethral prostate surgery (e.g. TUNA, TUMT, TURP) if performed within 1 year prior to screening, other local prostate cancer therapy (e.g., cryotherapy or brachytherapy) or previous pelvic irradiation at any time prior to screening. - History of prior pelvic surgery requiring low anterior or abdominoperineal resections or rectal surgery. - History of or active inflammatory bowel disease (IBD) such as Crohn's disease or ulcerative colitis. - History of or current perirectal disease that may interfere with interpretation of study outcomes including anal or perianal diseases such as fistula. - Bleeding hemorrhoids requiring medical intervention within the prior three months. - Diagnosed active bleeding disorder or a clinically significant coagulopathy. Note: Patients on anticoagulants may be included if the anticoagulant medication can be discontinued for index procedure. - Active inflammatory or infectious process involving the perineum, gastrointestinal (GI) or urinary tract based on positive diagnosis or suspected diagnosis in the presence of fever >38° C, WBC > 12,000/uL. - Compromised immune system or prior diagnoses for human immunodeficiency virus (HIV) (with a detectable viral load within the last 6 months)/acquired immunodeficiency syndrome (AIDS) or autoimmune disease. - If a subject was enrolled in another investigational drug or device trial that had not completed the primary endpoint or that clinically interfered with this study. - Unable to comply with the study requirements or follow-up schedule. - Any condition the Investigator believed would interfere with the intent of the study or would make participation not in the best interest of the patient. - Known iodine sensitivity or allergy - Known polyethylene glycol (PEG) sensitivity or allergy |
Country | Name | City | State |
---|---|---|---|
Australia | Sir Charles Gairdner Hospital | Nedlands | Western Australia |
Australia | Calvary Mater Newcastle | Waratah | New South Wales |
Australia | Princess Alexandra Hospital - ROPAIR | Woolloongabba | Queensland |
France | Institut Gustave Roussy | Villejuif | Cedex |
Germany | MEDICLIN Robert Janker Klinik | Bonn | |
Germany | Klinikum Nurnberg Nord | Nürnberg | |
Ireland | Bon Secours Radiotherapy Cork | Cork | |
Italy | Azienda Ospedaliero Universitaria di Parma | Parma | |
Italy | IRCCS Ospedale Sacro Cuore Don Calabria | Verona | |
Spain | Hospital Universitario Cruces | Barakaldo | |
Spain | GenesisCare, Hospital San Francisco de Asis | Madrid | |
Spain | Hospital Universitario Ramón y Cajal | Madrid | |
Switzerland | University Hospital Basel | Basel | |
Switzerland | Inselspital - University Hospital Bern | Bern | |
United Kingdom | Belfast City Hospital | Belfast | |
United Kingdom | Bristol Haematology and Oncology Centre | Bristol | |
United Kingdom | Velindre Cancer Centre | Cardiff | Wales |
United Kingdom | Royal Surrey County Hospital NHS Foundation Trust | Guildford | Surrey |
United Kingdom | Royal Marsden Hospital | London | |
United Kingdom | Norfolk and Norwich University Hospital NHS Trust | Norwich | |
United Kingdom | Derriford General Hospital | Plymouth | |
United States | New Jersey Urology, a Summit Health Company | Bloomfield | New Jersey |
United States | GenesisCare USA | Fort Myers | Florida |
United States | Kansas University Medical Center | Kansas City | Kansas |
United States | GenesisCare USA | Lakewood Ranch | Florida |
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
United States | Florida Urology Partners, LLC | Tampa | Florida |
United States | GenesisCare USA | Troy | Michigan |
Lead Sponsor | Collaborator |
---|---|
Boston Scientific Corporation |
United States, Australia, France, Germany, Ireland, Italy, Spain, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Late Gastrointestinal (GI) Toxicity | Proportion of subjects experiencing late GI toxicity after SBRT treatment with or without placement of the SpaceOAR Vue System hydrogel. Late GI toxicity is defined as the occurrence of a Grade 2 or greater GI adverse event (NCI CTCAE v4) between 3- and 24-months post-SBRT initiation | 3 to 24 months post-SBRT initiation | |
Secondary | EPIC-26 bowel score | Proportion of subjects experiencing a decrease in EPIC-26 bowel score greater than or equal to the minimal important difference (MID) in EPIC-26 bowel score from baseline to 24 months post-SBRT initiation. | 24 months post-SBRT initiation |
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