Active — Not RecruitingNot Applicable

SpaceIT Hydrogel System for Perirectal Spacing

United States230 participantsStarted 2024-10-30

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. Age ≥18 years old
✓. Subjects must have had pathologically confirmed (by routine hematoxylin and eosin \[H\&E\] staining) invasive adenocarcinoma of the prostate and planning to undergo EBRT
✓. Subjects must meet ALL of the following:
✓. Clinical stage T1-T2c (AJCC Ver. 8) tumor AND
✓. Gleason Score 7 or less as determined from a biopsy taken within 12 months of the Baseline visit AND
✓. 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)
✓. 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

✕. Prostate \> 80 cc
✕. Subjects who are planning to undergo brachytherapy or focal boost
✕. 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
✕. 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
✕. 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
✕. 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
✕. 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
✕. History of prior pelvic surgery requiring low anterior or abdominoperineal resections or rectal surgery

What they're measuring

Primary Safety Endpoint - Acute Grade 3 or greater adverse events.

Timeframe: 90 Days from hydrogel placement procedure

Primary Effectiveness Endpoint - 25% reduction in the volume of the rectum receiving 90% of the prescribed radiation dose

Timeframe: 10 days post procedure

Trial details

NCT IDNCT06451614

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-30

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