RECRUITING

SpaceIT Hydrogel System for Perirectal Spacing

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-10-30

Study Completion:2028-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06451614

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 meet ALL of the following: 1. Clinical stage T1-T2c (AJCC Ver. 8) 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	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 Note: MRI must be taken within 6 months prior to the Baseline visit 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., Transurethral Needle Ablation (TUNA), Transurethral Microwave Therapy (TUMT), Transurethral Resection of the Prostate (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, defined as PTT \> 70s or aPTT\>35s or INR \> 1.4, or platelet count \< 100,000 per mm3 Note: Subjects on anticoagulants may be included if the anticoagulant medication can be held for index procedure 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 \>38⁰ 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

Inclusion Criteria

Exclusion 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 meet ALL of the following:
1. Clinical stage T1-T2c (AJCC Ver. 8) 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

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 Note: MRI must be taken within 6 months prior to the Baseline visit
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., Transurethral Needle Ablation (TUNA), Transurethral Microwave Therapy (TUMT), Transurethral Resection of the Prostate (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, defined as PTT \> 70s or aPTT\>35s or INR \> 1.4, or platelet count \< 100,000 per mm3 Note: Subjects on anticoagulants may be included if the anticoagulant medication can be held for index procedure
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 \>38⁰ 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

Contacts and Locations

Study Contact

Kaitlyn Rainbow

CONTACT

952-930-6000

kat.rainbow@bsci.com

Amara Balhorn

CONTACT

952-930-6000

amara.balhorn@bsci.com

Principal Investigator

Brian Baumann, MD

PRINCIPAL_INVESTIGATOR

Springfield Clinic

Study Locations (Sites)

Baptist Hospital of Miami

Miami, Florida, 33176

United States

Collaborators and Investigators

Sponsor: Boston Scientific Corporation

Brian Baumann, MD, PRINCIPAL_INVESTIGATOR, Springfield Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-30

Study Completion Date2028-03-31

Study Record Updates

Study Start Date2024-10-30

Study Completion Date2028-03-31

Terms related to this study

Additional Relevant MeSH Terms

Prostate Cancer