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Prostate Cancer Patients Treated by RadiotherapyOASISNCT07300631

SpaceOAR Post-Market Registry Study

An observational study of Prostate Cancer Patients Treated by Radiotherapy, run by Sheffield Teaching Hospitals NHS Foundation Trust at 8 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Recently, concerns have been raised by regulators that there is little data about the long-term safety of rectal hydrogel spacers for use in conjunction with radiotherapy treatment for prostate cancer. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
SpaceOAR / SpaceOAR Vue hydrogel system
Type of treatment
Medical device
How many people
320 participants
Where
8 sitesin 2 countries
Study dates
31 Dec 2025to Feb 2030
How long will I take part?
3 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: Men with prostate cancer having radiotherapy with curative intent and having a SpaceOAR as part of standard care.

Who may be able to join

  • All patients with a clinical diagnosis of prostate cancer planned to undergo treatment with curative intent at selected sites in the UK \& France subject to a SpaceOAR being used as usual care.
  • Aged 18 years old or above.
  • Patients who agrees to participate and has been deemed by their medical team to have capacity to provide;
  • verbal, informed consent over telephone as documented on the study informed consent form by the Researchers (UK only)
  • written, informed consent by signature of the study informed consent form (France only)
  • Patient covered by social security scheme (France only)

Who cannot join

  • Patients lacking the capacity to provide;
  • informed consent as documented on the study informed consent form by the - Researchers (UK only)
  • written, informed consent by signature of the study informed consent form (France only)

Trial locations and contacts

8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

8 sites in 2 countries

United Kingdom5 sites, 5 recruiting

  • University Hospitals of Derby & Burton NHS Foundation Trust

    Derby, Derbyshire, DE22 3NE

    Prantik Das, 01332 340131, prantik.das3@nhs.net

    Prantik Das

    Recruiting

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Liverpool, L7 8YA

    Isabel Syndikus, 01513344000, isabel.syndikus@nhs.net

    Isabel Syndikus

    Recruiting

  • Royal Free London

    London, NW3 2QG

    Amy Clifford, 020 3758 2000, amy.clifford3@nhs.net

    Amy Clifford

    Recruiting

  • Maidstone & Tunbridge Wells NHS Trust

    Maidstone, ME16 9QQ

    Albert Edwards, +1622729000, albert.edwards@nhs.net

    Albert Edwards

    Recruiting

  • Norfolk & Norwich University Hospital NHS Foundation Trust

    Norwich, NR 7UY

    Jenny Nobes, 4416603286286, jenny.nobes@nnuh.nhs.uk

    Jenny Nobes

    Recruiting

Other trials in United Kingdom

France3 sites, 3 recruiting

  • CHU de Brest, Boulevard de Tanguy Prigent

    Brest, 29200

    Ulrike Pr SCHICK, 0298223398, ulrikeschick@chu-brest.fr

    Ulrike Schick

    Recruiting

  • Clinique Pasteur

    Toulouse, 31300

    Igor Latorzeff, +33 5 62 21 31 31, ilatorzeff@clinique-pasteur.com

    Recruiting

  • Centre de cancérologie Les Dentellières

    Valenciennes, 59300

    Benjamin Vandendorpe, +33 3 27 09 10 10, bvandendorpe@lesdentellieres.com

    Recruiting

Other trials in France

About this study

Official title: OASIS: SpaceOAR PoSt - Market Registry Study: Assessing the Safety & Acceptability of SpaceOAR Use With Prostate Radiotherapy

Recently, concerns have been raised by regulators that there is little data about the long-term safety of rectal hydrogel spacers for use in conjunction with radiotherapy treatment for prostate cancer. To address this, this study will collect data about the short-term side-effects and long-term safety of SpaceOAR and SpaceOAR Vue rectal hydrogel spacers in men who receive them in the UK and France. Men who have agreed to receive these spacers as part of their standard medical care will be asked to take part in the study whereby data about their treatment and health will be collected from their medical records and from members of the clinical team who deliver their treatment. Additionally, men will be asked to consent to completing questionnaires about their experiences of side effects from their treatment. Further information will be collected about their clinical characteristics before they receive a spacer, the physician-rated clinical performance of the spacer insertion procedure, their radiotherapy treatment plan and details of the other treatments they are also receiving which could influence the types and extent of side effects they experience. Data collection will span eight time points: pre-spacer insertion, spacer insertion, the start of radiotherapy, post-radiotherapy follow-up, 6-month follow-up, 12-month follow-up, 24-month follow-up \& 36-month follow-ups. Outside of these timepoints treatment-related adverse event data will be concurrently reported and collated. Participants' treatments will not be changed as a result of their participation in this study. Data from this study will be used to summarise the characteristics of this study population, physicians' perceptions of the spacer implantation procedure, the radiotherapy treatments plans made, and the types, extent and timing of treatment-related adverse events and side effects.

Being tested
SpaceOAR / SpaceOAR Vue hydrogel system
Keywords
rectal spacer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SpaceOAR / SpaceOAR Vue hydrogel systemDevice

    Space OAR/SpaceOAR Vue Systems are biodegradable medical devices that are implanted between the prostate and rectum to temporarily move part of the rectal wall away from the prostate during radiation therapy for prostate cancer.

Study groups in NCT07300631
Study groupRoleWhat they receive
All participantsParticipants receiving prostate cancer care in the UK and France
Receives: Device: SpaceOAR / SpaceOAR Vue hydrogel system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Short-term safety of SpaceOAR/SpaceOAR Vue systems.

    Proportion of subjects experiencing any of the following within 30 days post-implantation of SpaceOAR/SpaceOAR Vue hydrogel, as adjudicated by the Independent Clinical Events Committee:

    • Symptoms (PROMs): Measured using validated patient-reported outcome questionnaires. A subject is counted if any PROM score exceeds the predefined threshold for clinically significant symptoms.
    • Adverse Events (CTCAE v5.0): Measured as the occurrence of any adverse event graded per CTCAE v5.0.
    • Abnormal Imaging (MRI/CT): A subject is counted if any abnormality is confirmed by radiology review.
    • The study instruments in the French population with include Grade 1 and above events (CTCAEv5.0)
    • Unit of Measure: Percentage of subjects (%)
    • Each category will be reported separately.

    Measured: 30 days post-implantation

  2. Long-Term Safety of SpaceOAR/SpaceOAR Vue Systems

    Proportion of subjects experiencing Grade ≥2 gastrointestinal or anorectal toxicity (per CTCAE v5.0) within 3 years after completion of radiation therapy.

    • The study instruments in the French population with include Grade 1 and above events (CTCAEv5.0)
    • Unit of Measure: Percentage of subjects (%)

    Measured: Up to 3 years post-radiation therapy

Secondary outcomes (10)

  1. Proportion of subjects with Grade 2* & above; gastrointestinal, anorectal, genitourinary toxicity at 12, 24 & 36 months.

    Proportion of subjects experiencing Grade ≥2 toxicity (as per CTCAE v5.0) in gastrointestinal, anorectal, or genitourinary systems at 12, 24, and 36 months post-radiation therapy.

    • Unit of Measure: Percentage of subjects (%) Note: For French population, Grade ≥1 events will also be included.

    Measured: 12, 24, and 36 months post-radiation therapy

  2. Physician rating of SpaceOAR/SpaceOAR Vue of Placement Difficulty

    Rated on a Likert scale (1 = very difficult, 5 = very easy) immediately after procedure.

    Unit of Measure: Mean Likert score

    Measured: At time of implantation

  3. Patient Perception of SpaceOAR/SpaceOAR Vue Procedure Compared to Prostate Biopsy

    Measured using a structured questionnaire comparing perceived discomfort and acceptability relative to prostate biopsy.

    • Unit of Measure: Percentage of subjects reporting "less discomfort," "similar," or "more discomfort

    Measured: Within 30 days post-procedure

  4. Overall Mortality and Cause of Death

    Number and proportion of subjects who die during the study period, with cause adjudicated by Independent Clinical Events Committee.

    • Unit of Measure: Number of deaths and percentage (%)

    Measured: Up to 36 months

  5. Selection Criteria for SpaceOAR/SpaceOAR Vue Placement

    Analysis of baseline clinical and demographic factors associated with successful placement.

    • Unit of Measure: Descriptive statistics (frequency, percentage)

    Measured: At enrolment

  6. Time to Onset of Grade ≥2 Gastrointestinal, Anorectal, and Genitourinary Toxicity

    Measured as time (in months) from radiation therapy completion to first occurrence of Grade ≥2 toxicity (per CTCAE v5.0).

    • Unit of Measure: Median time to onset (months)

    Measured: Up to 36 months

  7. Impact of treatment on bowel function, urinary function, sexual function and overall quality of life as measured by EPIC-26

    The EPIC-26 questionnaire is a preeminent tool extensively characterised to measure health-related quality of life in men with localised prostate cancer across specific domains

    • Urinary function
    • Bowel function
    • Sexual function
    • Effects of hormone treatment Scores range from 0-100, with higher scores indicating better function or quality of life.

    Unit of Measure: Mean score change from baseline (points)

    Measured: Baseline, 12, 24 and 36 months

  8. Impact of treatment on bowel function, urinary function, sexual function and overall quality of life as measured by IPSS

    International Prostate Symptom Score (IPSS). IPSS assesses urinary voiding symptoms and bother.

    For voiding symptoms, a score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms, and the urinary bother scale ranges from 0 (Delighted) to 6 (Terrible).

    Unit of Measure: Mean score change from baseline (points)

    Measured: Baseline, 12, 24 and 36 months

  9. Impact of treatment on bowel function as measured by Vaizey incontinence score

    The Vaizey Incontinence Score is a general-purpose scale for faecal incontinence that ranges from 0 to 24 with higher scores representing worst incontinence.

    Unit of Measure: Mean score change from baseline (points)

    Measured: Baseline, 12, 24 and 36 months

  10. Impact of concomitant prostate cancer treatment usually Androgen Deprivation Therapy (ADT) on the lives of participants as measured by The Symptom Index

    The Symptom Index is an un-validated questionnaire which has been developed to capture the impact of the side effects of concomitant prostate cancer treatment (usually ADT} on the lives of participants. The questions capture the quality of life using the scale: 0 - 4, with higher scores indicating worse symptoms or quality of life.

    Unit of measure: Mean score change from baseline (points)

    Measured: Baseline, 12, 24, 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2025
  2. Study start31 Dec 2025
  3. Primary completionFeb 2030 (estimated)
  4. Study completionFeb 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
320 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07300631
Sponsor's protocol ID
STH22555
Other IDs
IRAS Project ID: 341038
Acronym
OASIS
Status last verified
Jul 2026
First submitted
19 Nov 2025
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer Patients Treated by Radiotherapy, run by Sheffield Teaching Hospitals NHS Foundation Trust at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United Kingdom, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Short-term safety of SpaceOAR/SpaceOAR Vue systems. (time frame: 30 days post-implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07300631.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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