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JOURNAL ONKOLOGIE – STUDIE
SABRE

Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy

Rekrutierend

NCT-Nummer:
NCT04905069

Studienbeginn:
Dezember 2021

Letztes Update:
23.04.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Prostatic Neoplasms

Geschlecht:
Männer

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Boston Scientific Corporation

Collaborator:
-

Studienleiter

Suneil Jain, MB, BCh, PhD
Principal Investigator
Queen's University, Belfast

Kontakt

Studienlocations
(3 von 28)

MEDICLIN Robert Janker Klinik
D-53129 Bonn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Klinikum Nurnberg Nord
90419 Nürnberg
(Bayern)
GermanyRekrutierend» Google-Maps
GenesisCare USA
33908 Fort Myers
United StatesAktiv, nicht rekrutierend» Google-Maps
GenesisCare USA
34202 Lakewood Ranch
United StatesRekrutierend» Google-Maps
Florida Urology Partners, LLC
33609 Tampa
United StatesRekrutierend» Google-Maps
Kansas University Medical Center
66160 Kansas City
United StatesAktiv, nicht rekrutierend» Google-Maps
New Jersey Urology, a Summit Health Company
07003 Bloomfield
United StatesRekrutierend» Google-Maps
University of Pittsburgh Medical Center
15232 Pittsburgh
United StatesRekrutierend» Google-Maps
Princess Alexandra Hospital - ROPAIR
4102 Woolloongabba
AustraliaRekrutierend» Google-Maps
Sir Charles Gairdner Hospital
6009 Nedlands
AustraliaRekrutierend» Google-Maps
Bon Secours Radiotherapy Cork
T12 DV56 Cork
IrelandRekrutierend» Google-Maps
Azienda Ospedaliero Universitaria di Parma
43126 Parma
ItalyRekrutierend» Google-Maps
IRCCS Ospedale Sacro Cuore Don Calabria
37024 Verona
ItalyRekrutierend» Google-Maps
Hospital Universitario Cruces
48903 Barakaldo
SpainRekrutierend» Google-Maps
GenesisCare, Hospital San Francisco de Asis
28002 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Ramón y Cajal
Madrid
SpainRekrutierend» Google-Maps
University Hospital Basel
CH-4031 Basel
SwitzerlandRekrutierend» Google-Maps
Inselspital - University Hospital Bern
3010 Bern
SwitzerlandRekrutierend» Google-Maps
Royal Surrey County Hospital NHS Foundation Trust
GU27XX Guildford
United KingdomRekrutierend» Google-Maps
Velindre Cancer Centre
CF14 2TL Cardiff
United KingdomRekrutierend» Google-Maps
Belfast City Hospital
BT9 7AB Belfast
United KingdomRekrutierend» Google-Maps
Bristol Haematology and Oncology Centre
BS2 8ED Bristol
United KingdomRekrutierend» Google-Maps
Royal Marsden Hospital
SW3 6JJ London
United KingdomRekrutierend» Google-Maps
Norfolk and Norwich University Hospital NHS Trust
NR4 7UY Norwich
United KingdomRekrutierend» Google-Maps
Derriford General Hospital
PL6 8DH Plymouth
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

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.

Ein-/Ausschlusskriterien

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 >38⁰ 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

Studien-Rationale

Primary outcome:

1. Late Gastrointestinal (GI) Toxicity (Time Frame - 3 to 24 months post-SBRT initiation):
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



Secondary outcome:

1. EPIC-26 bowel score (Time Frame - 24 months post-SBRT initiation):
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.

Studien-Arme

  • No Intervention: No-Spacer Control
    Subjects will receive radiotherapy without the use of the SpaceOAR Vue.
  • Experimental: SpaceOAR Vue
    Subjects will receive radiotherapy following injection of the SpaceOAR Vue hydrogel.

Geprüfte Regime

  • SpaceOAR Vue System:
    The SpaceOAR Vue System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of the SpaceOAR Vue System to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR Vue System is composed of biodegradable material, maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.

Quelle: ClinicalTrials.gov


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