SpaceIT Hydrogel System for Perirectal Spacing

Prostate Cancer Clinical Trial

— HYDROSPACE  

Official title:

SpaceIT Hydrogel System for Perirectal Spacing in Subjects With Low to Intermediate Risk Prostate Cancer Undergoing External Beam Radiotherapy (EBRT)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06451614
• Other study ID #: U0755
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2024
• Source: Boston Scientific Corporation
• Contact: Reshma Rao
• Phone: 952-930-6000
• Email: reshma.rao[@]bsci.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and effectiveness of the SpaceIT™ Hydrogel System in patients undergoing External Beam Radiotherapy (EBRT) for the treatment of prostate cancer.

Description:

HYDROSPACE study is a prospective, randomized, multicenter study to evaluate the safety and effectiveness of SpaceIT in patients undergoing External Beam Radiotherapy (EBRT) for the treatment of prostate cancer. Subjects randomized to the investigational arm will receive SpaceIT Hydrogel System Subjects randomized to the control arm will receive a commercially marketed Boston Scientific perirectal hydrogel spacer, SpaceOAR System or SpaceOAR Vue Hydrogel

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 230
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18 years old

2. Subjects must have had pathologically confirmed (by routine hematoxylin and eosin [H&E] staining) invasive adenocarcinoma of the prostate and planning to undergo EBRT

3. Subjects must have ALL of the following:

1. Clinical stage T1-T2c (AJCC Ver. 9) tumor AND

2. Gleason Score 7 or less as determined from a biopsy taken within 12 months of the Baseline visit AND

3. Demonstrated blood prostate specific antigen (PSA) levels =20 ng/ml as measured within 6 months of the Baseline visit and prior to commencing androgen deprivation therapy (ADT)

4. Subject is able to provide written informed consent, approved by the appropriate Institutional Review Board/Ethics Committee/Research Ethics Board (IRB/EC/REB) of the respective clinical site

Exclusion Criteria:

1. Prostate > 80 cc

2. Subjects who are planning to undergo brachytherapy or focal boost

3. Subjects who have magnetic resonance imaging (MRI) evidence of gross posterior extracapsular extension (ECE) of the prostate cancer

4. Subjects who have metastatic disease, other ongoing cancers which are being treated during the study or subjects for whom pelvic lymph node radiotherapy is planned

5. Subjects with any prior invasive solid tumor malignancy or hematologic malignancy (except non-melanomatous skin cancer) unless the subject has been disease free and treatment free for a minimum of 3 years

6. History of radical prostatectomy, other ablative anti-prostate cancer therapy (e.g., cryotherapy, high intensity focused ultrasound, irreversible electroporation) or previous pelvic irradiation (including prior prostate brachytherapy) at any time prior to screening

7. History of transurethral prostate surgery (e.g., TUNA, TUMT, TURP) if performed within 1 year prior to screening

8. History of prior pelvic surgery requiring low anterior or abdominoperineal resections or rectal surgery

9. History of or current perirectal disease that may interfere with interpretation of study outcomes, including anal or perianal diseases such as fistula

10. Bleeding hemorrhoids requiring medical intervention within the prior three months

11. Diagnosed active bleeding disorder or a clinically significant coagulopathy

12. Active inflammatory or infectious process involving the perineum, GI or urinary tract based on positive diagnosis or suspected diagnosis in the presence of fever >38° C, WBC > 12,000/uL

13. Inability to undergo pelvic MRI or presence of implants causing severe artifact (e.g. bilateral arthroplasty) that interferes with imaging interpretation for this study at Investigator discretion

14. 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

15. Unable to comply with the study requirements or follow-up schedule

16. 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

17. Known PEG (polyethylene glycol) sensitivity or allergy

18. Known iodine sensitivity or allergy

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• SpaceIT Hydrogel System
SpaceIT Hydrogel 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 SpaceIT Hydrogel System to reduce the radiation dose delivered to the anterior rectum. The SpaceIT Hydrogel System is composed of a radiopaque, biodegradable material designed to maintain space for approximately 12 weeks and be absorbed in about 6 months, sufficient time to support the intended use. SpaceIT has an iodinated PEG powder making it radiopaque.
• Commercially available Boston Scientific Spacer
Boston Scientific's commercially available SpaceOAR Hydrogel System or SpaceOAR Vue Hydrogel 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 SpaceOAR Hydrogel System or SpaceOAR Vue Hydrogel System to reduce the radiation dose delivered to the anterior rectum. SpaceOAR and SpaceOAR Vue are both perirectal spacers. SpaceOAR Vue specifically has an iodinated PEG powder making it radiopaque. SpaceOAR does not contain iodinated PEG powder and is not radiopaque. The SpaceOAR Hydrogel System or SpaceOAR Vue Hydrogel System maintains space during prostate radiotherapy treatment and is completely absorbed by the patient's body over time.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Endpoint - Acute Grade 3 or greater adverse events related to the hydrogel placement or hydrogel misplacement resulting in a delay or cancellation of radiotherapy	Acute Grade 3 or greater adverse events related to the hydrogel placement or hydrogel misplacement resulting in a delay or cancellation of radiotherapy within 90 days of index procedure.	90 Days from hydrogel placement procedure
Primary	Primary Effectiveness Endpoint - 25% reduction in the volume of the rectum receiving 90% of the prescribed radiation dose	Clinically relevant dose reduction defined as a 25% reduction in the volume of the rectum receiving 90% of the prescribed radiation dose in subjects receiving hydrogel.	10 days post procedure
Secondary	Additional Safety Endpoint - Adverse Device Effects (ADEs) requiring additional procedures and/or medications	Adverse Device Effects (ADEs) requiring additional procedures and/or medications	Up to 24 months
Secondary	Additional Safety Endpoint - Incidence of acute Grade 2 or greater gastrointestinal (GI) and genitourinary (GU) adverse events (AEs)	Incidence of acute Grade 2 or greater gastrointestinal (GI) and genitourinary (GU) adverse events (AEs) from index procedure up to 3 months	Up to 90 days
Secondary	Additional Safety Endpoint - Incidence of late Grade 2 or greater GI and GU adverse events (AEs)	Incidence of late Grade 2 or greater GI and GU adverse events (AEs) from 3 months up to the end of study follow-up	91 days up to 24 Months
Secondary	Additional Effectiveness Endpoint - Visualization of hydrogel	Technical Success: visualization of hydrogel between the posterior prostatic capsule and the anterior rectal wall will be assessed as Yes/No using the MRI performed post hydrogel placement procedure	10 days post procedure
Secondary	Additional Effectiveness Endpoint - Space Creation	Space Creation: Distance between the posterior prostatic capsule and anterior rectal wall will be measured mid gland in millimeters using MRI performed post hydrogel placement procedure	10 days post procedure
Secondary	Additional Effectiveness Endpoint - Absorption	Absorption: Absence of hydrogel in the perirectal space assessed on MRI at 12 months post-hydrogel placement.	12 Month post hydrogel placement
Secondary	Additional Effectiveness Endpoint - Change in radiation dose distributions to the organs at risk	Dose Distribution: Change in radiation dose distributions to the organs at risk (OARs) quantified by computing rectal Dose-Volume Histograms (DVHs) for the dose plans created pre-and post-hydrogel placement.	10 days post procedure
Secondary	Additional Effectiveness Endpoint - Mean and Maximum Rectal Radiation doses	Mean and Maximum Rectal Radiation Doses (in Gy)	10 days post procedure
Secondary	Additional Effectiveness Endpoint - Quality of Life Questionnaire: EQ-5D-5L	Changes from Baseline in EQ-5D-5L; The EQ-5D-5L is a generic questionnaire that assesses a subject's self-reported health status in terms of five dimensions of health: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. Subject's overall current health on a vertical visual analogue scale of "0-100" is recorded, where the endpoints are labelled 'The best health you can imagine' at "100" and 'The worst health you can imagine' at "0".	Baseline up to 24 months
Secondary	Additional Effectiveness Endpoint - Ease of hydrogel administration	Ease of hydrogel administration. Scored on a Likert scale from 1 to 5 where 1 is Very Difficult and 5 is Very Easy	10 days post procedure
Secondary	Additional Effectiveness Endpoint - Space Maintenance	Space Maintenance: Distance between the posterior prostatic capsule and anterior rectal wall will be measured	3 Months post hydrogel placement procedure
Secondary	Additional Effectiveness Endpoint - Quality of Life Questionnaire: Expanded Prostate Cancer Index Composite (EPIC-26)	Changes from Baseline in Expanded Prostate Cancer Index Composite (EPIC-26); EPIC-26 is a questionnaire designed to measure health related quality of life (HRQOL) in people with prostate cancer. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL.	Baseline up to 24 months
Secondary	Additional Effectiveness Endpoint - Quality of Life Questionnaire, Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH)	Changes from Baseline in Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH); The Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.	Baseline up to 24 months