Prostate Cancer Patients Treated by RadiotherapyNCT01999660
Post-marketing Surveillance Regarding Efficacy and Safety of SpaceOAR™
An observational study of Prostate Cancer Patients Treated by Radiotherapy, run by CS Diagnostics GmbH at 1 site in Germany.
Trial summary
A treatment with SpaceOAR™ hydrogel does reduce late toxicity Grad 2 and Grad 3 of radiation therapy in prostate cancer patients Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Patients Treated by Radiotherapy
- What is being tested?
- SpaceOAR™ implantation
- Type of treatment
- Medical device
- How many people
- 119 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2013to Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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: prostate cancer patients treated by radiotherapy and prophetically by SpaceOAR™
Who may be able to join
- Patient is suffering from pathologically confirmed T1-T2, N0, M0 prostate adenocarcinoma.
- Patient is intended to receive radiation therapy (3D-computerized radiotherapy, intensity-modulated radiotherapy, and/or brachytherapy) and this will be the first prostate or pelvic radiation therapy.
- Patient is intended to receive SpaceOAR™ Gel therapy.
- The patient is official patient of the clinical investigator in the study centre.
- Patient agrees to fully participate in the clinical trial and give informed consent in writing.
Who cannot join
- Anatomic abnormality, physical or pathological condition precluding the implantation.
- Failure in the wall of the perineum room (with the risk that the hydrogel escapes).
- History of prostate surgery or local prostate cancer therapy.
- Rectal injury before implantation of SpaceOAR™ Gel or history of or active inflammatory rectal disease such as Crohn's disease or ulcerative colitis.
- History of or current perirectal or anal disease or surgery such as prolapsed or bleeding haemorrhoids or fistula.
- Compromised immune system (e.g., HIV/acquired immunodeficiency syndrome, auto¬immune disease or immunosuppressive therapy).
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- Platelet count, partial thromboplastin time, or white blood cell count out of normal laboratory range.
- Contraindication for safe MRI and CT scans.
- Patient is not able to fully participate in this study including the follow-up (e.g. for mental or geographical reasons, or patient is intravenous drug user or has strong potential for non-compliance to medical regimes).
- Patient is mentally unable to understand the nature, aims, or possible consequences of the clinical investigation.
- Patient has restricted legal capacity.
- Patient did participate in another clinical investigation during the last 3 months.
- Patient has revoked the consent.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic for Radiooncology and Radiotherapy, Evangelical Clinics Gelsenkirchen
Gelsenkirchen, North Rhine-Westphalia, 45879
About this study
Official title: Prospective National Post-marketing Surveillance for the Investigation of the Efficacy and Safety of SpaceOAR™ to Maintain Space Between the Rectum and Prostate During Radiation Therapy
A treatment with SpaceOAR™ hydrogel does reduce late toxicity Grad 2 and Grad 3 of radiation therapy in prostate cancer patients
Read the detailed description
The degradable SpaceOAR™ hydrogel establishes for the time of radiotherapy a distance between the prostate and the rectum
- Being tested
- SpaceOAR™ implantation
- Keywords
- Prostatic Neoplasms, Radiotherapy, rectal toxicity
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpaceOAR™ implantationDevice
| Study group | Role | What they receive |
|---|---|---|
| SpaceOAR™ | prostate cancer patient prophetically treated by SpaceOAR™ Receives: Device: SpaceOAR™ implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rectal complication rate (late toxicity)
the rectal complication rate following the common toxicity criteria (CTC) v. 2.0
Measured: 6 months and yearly for 5 years thereafter
Secondary outcomes (1)
Quality of Life
The validated Expanded Prostate Cancer Index Composite (EPIC) questionnaire in combination with the validated Short Form Health Survey (SF-12) will be used to document the influence on the quality of life (QoL).
Measured: 6 months and for 5 years yearly thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionAug 2019
- Study completionAug 2019
Why it stopped: PI did leave hospital (retired)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer Patients Treated by RadiotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- CS Diagnostics GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aix Scientifics
- Responsible party
- Sponsor
- Investigators
- Razvan Galalae, PD Dr. med., Principal investigator, Clinic for Radiooncology and Radiotherapy, Evangelical Clinics Gelsenkirchen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01999660
- Sponsor's protocol ID
- Space-CS-01
- Status last verified
- Jul 2021
- First submitted
- 26 Nov 2013
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective National Post-marketing Surveillance for the Investigation of the Efficacy and Safety of SpaceOAR™ to Maintain Space Between the Rectum and Prostate During Radiation Therapy
- ClinicalTrials.gov ID
- NCT01999660
- Acronym / sponsor ID
- Space-CS-01
- Keywords
- Prostatic Neoplasms, Radiotherapy, rectal toxicity
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI did leave hospital (retired)
- Enrolment
- 119 participants (actual)
- Lead sponsor
- CS Diagnostics GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Aix Scientifics
- Study start
- Nov 2013
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 3 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A treatment with SpaceOAR™ hydrogel does reduce late toxicity Grad 2 and Grad 3 of radiation therapy in prostate cancer patients
Detailed description
The degradable SpaceOAR™ hydrogel establishes for the time of radiotherapy a distance between the prostate and the rectum
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SpaceOAR™ | – | Device: SpaceOAR™ implantationprostate cancer patient prophetically treated by SpaceOAR™ |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- prostate cancer patients treated by radiotherapy and prophetically by SpaceOAR™
Key inclusion criteria (5 listed)
- Patient is suffering from pathologically confirmed T1-T2, N0, M0 prostate adenocarcinoma.
- Patient is intended to receive radiation therapy (3D-computerized radiotherapy, intensity-modulated radiotherapy, and/or brachytherapy) and this will be the first prostate or pelvic radiation therapy.
- Patient is intended to receive SpaceOAR™ Gel therapy.
- The patient is official patient of the clinical investigator in the study centre.
- Patient agrees to fully participate in the clinical trial and give informed consent in writing.
Key exclusion criteria (13 listed)
- Anatomic abnormality, physical or pathological condition precluding the implantation.
- Failure in the wall of the perineum room (with the risk that the hydrogel escapes).
- History of prostate surgery or local prostate cancer therapy.
- Rectal injury before implantation of SpaceOAR™ Gel or history of or active inflammatory rectal disease such as Crohn's disease or ulcerative colitis.
- History of or current perirectal or anal disease or surgery such as prolapsed or bleeding haemorrhoids or fistula.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpaceOAR™ implantation | Device | SpaceOAR™ |
Primary outcome
the rectal complication rate (late toxicity)
Time frame: 6 months and yearly for 5 years thereafter
the rectal complication rate following the common toxicity criteria (CTC) v. 2.0
1 secondary outcome
Quality of Life
Time frame: 6 months and for 5 years yearly thereafter
Results and safety
The study was stopped early (reason given: PI did leave hospital (retired)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Razvan Galalae, PD Dr. med. principal investigator
Clinic for Radiooncology and Radiotherapy, Evangelical Clinics Gelsenkirchen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer Patients Treated by Radiotherapy, run by CS Diagnostics GmbH at 1 site in Germany.
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 5 inclusion and 13 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: stopped early, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
The study was stopped early (reason given: PI did leave hospital (retired)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rectal complication rate (late toxicity) (time frame: 6 months and yearly for 5 years thereafter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2021.