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    Interventional procedure overview of biodegradable spacer insertion to reduce rectal toxicity during radiotherapy for prostate cancer

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    Additional information considered by IPAC

    Professional experts' opinions

    Expert advice was sought from consultants who have been nominated or ratified by their professional Society or Royal College. The advice received is their individual opinion and is not intended to represent the view of the society. The advice provided by professional experts, in the form of the completed questionnaires, is normally published in full on the NICE website during public consultation, except in circumstances but not limited to, where comments are considered voluminous, or publication would be unlawful or inappropriate.

    9 professional expert questionnaires for biodegradable spacer insertion to reduce rectal toxicity during radiotherapy for prostate cancer were submitted and can be found on the NICE website.

    Patient organisation opinions

    One patient organisation submission for biodegradable spacer insertion to reduce rectal toxicity during radiotherapy for prostate cancer was received and can be found on the NICE website.

    Patient commentators' opinions

    NICE's Public Involvement Programme sent questionnaires to NHS trusts for distribution to patients who had the procedure (or their carers). NICE received 22 completed questionnaires.

    The patient commentators' views on the procedure were consistent with the published evidence and the opinions of the professional experts. See the patient commentary summary for more information.]

    Company engagement

    A structured information request was sent to 3 companies who manufacture a potentially relevant device for use in this procedure. NICE received 2 completed submissions. These were considered by the IP team and any relevant points have been taken into consideration when preparing this overview.

    Issues for consideration by IPAC

    Ongoing studies:

    • NCT02353832 Stereotactic ablative radiotherapy (SABR) for low risk prostate cancer with injectable rectal spacer (phase 2 study); interventional single group; n=44; device: SpaceOAR, Duraseal or equivalent; primary outcome: percentage of participants with reduction in acute per-prostatic rectal ulcer events from 90%+ to <70%, effectiveness of space creation of >= 7.5 mm in protecting rectum from toxicity; location: USA; study completion date: January 2021; status: active.

    • NCT02361515 Moderate hypofractionated radiotherapy (62 Gy in 20 fractions of 3.1 Gy) versus stereotactic radiotherapy (37.5 Gy in 5 fractions of 7.5 Gy) with hyaluronic acid injection between the prostate and the rectum for prostate cancer of low- to intermediate risk; RPAH2. RCT, n=96, primary outcome - number of patients with late urinary toxicities of grade ≥ 2; location France; study completion date: September 2019.

    • NCT02165020: Hypofractionated radiotherapy for prostate cancer (62 Gy in 20 fractions of 3.1 Gy) with hyaluronic acid injection; non-randomised single group study, n=36, primary outcome: number of patients with late rectal toxicities (> 3 months) of grade ≥ 2; location France; study completion May 2017; status active.

    • NCT03386045: Optimal prostate fractionation study; RCT, n=214, moderate hypofractionation or standard radiotherapy plus SBRT (BOOSTER) with hydrogel versus moderate hypofractionation or SBRT; primary outcome: local control; location Australia; study completion date: March 2026, status recruiting.

    • NCT03400150: clinical protocol for the investigation of the ProSpace™ balloon system pivotal study BP-007; RCT, n=222, ProSpace balloon in prostate cancer during IMRT versus only IMRT; primary outcomes: adverse event rate, reduction in rectal radiation exposure at 6 months; international study; study completion date: April 2022; status active.

    • NCT03525262 A phase II randomized controlled trial of stereotactic ablative body radiotherapy (SABR) with or without neurovascular sparing for erectile function preservation in localized prostate cancer, hydrogel used in the intervention group. RCT, n=120, primary outcome: reduction in EPIC sexual function domain composite score; location USA, study completion date: June 2024; status recruiting.

    • ACTRN12612000524897:  A trial of polyethylene glycol (PEG) hydrogel to reduce rectal radiation dose during radiotherapy for prostate cancer. Nonrandomised single group study, n=40; primary outcomes: radiation dose, prostate rectum separation, toxicity; location Australia, completion date and status unknown.