Prostatic CancerPhase 2/3NoHarmNCT01787630
To Evaluate the Technique and Effects of Separating the Prostate and Rectum With Hyaluronic Acid During Radiotherapy
A Phase 2/3 study testing Hyaluronic acid in people with Prostatic Cancer, run by Anders Widmark at 3 sites in Sweden.
Trial summary
The dominating problem after local radiotherapy of prostate cancer is rectal toxicity. If the rectum could be completely moved out of the treated volume, a substantial decrease of rectal toxicity seems reasonable. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostatic Cancer
- What is being tested?
- Hyaluronic acid
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 3 sitesSweden
- Study dates
- Jan 2010to Mar 2021
- Phase
- Phase 2/3
- 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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically verified prostatic cancer
- Low or intermediate risk prostatic cancer
- Lymph node negative
- Suitable for radiotherapy
Who cannot join
- Earlier treatment for prostatic cancer
- Unable to co-operate or suffering from any other form of disease that would interfere with the planned treatment
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Department of oncology, Kalmar Hospital
Kalmar, SE-39244
Department of oncilogy, Sundsvall Hospital
Sundsvall, SE-851 86
Department of oncology, University Hospital
Umeå, SE-901 85
About this study
Official title: Initiating Phase II-III Study to Evaluate the Technique and Effects of Separating the Prostate From the Rectum With Hyaluronic Acid During Radiotherapy
The dominating problem after local radiotherapy of prostate cancer is rectal toxicity. If the rectum could be completely moved out of the treated volume, a substantial decrease of rectal toxicity seems reasonable. In this study we will develop and evaluate a new transrectal injection technique where hyaluronic acid (HA) is injected in the space between the prostate and the rectum prior to external beam radiotherapy to increase the physical distance between prostate and rectum.
- Conditions
- Prostatic Cancer
- Being tested
- Hyaluronic acid
- Keywords
- Prostatic cancer, Radiotherapy, Hyaluronic acid
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acidDevice
Also called NASHA Spacer Gel
Injection in connection with ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid | Experimental | Hyaluronic acid will be injected in the space between the prostate and rectum prior to radiotherapy to perform a dorsal movement of rectum. Receives: Device: Hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remaining volume of HA
Measurement on the remaining volume of HA by MRI
Measured: 24 month after end of radiotherapy
Secondary outcomes (1)
Quality of life
Patient evaluation with questionnaires regarding Quality of Life and side effects after radiotherapy
Measured: 24 month after end of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startJan 2010
- Primary completionMar 2016
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic CancerStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anders Widmark
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Umeå
- Responsible party
- Sponsor-investigator, Anders Widmark, Umeå University
- Investigators
- Anders Widmark, Prof MD, Principal investigator, Umea university, dept of oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787630
- Sponsor's protocol ID
- NoHarm1
- Acronym
- NoHarm
- Status last verified
- Nov 2016
- First submitted
- 6 Feb 2013
- Last updated
- 4 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initiating Phase II-III Study to Evaluate the Technique and Effects of Separating the Prostate From the Rectum With Hyaluronic Acid During Radiotherapy
- ClinicalTrials.gov ID
- NCT01787630
- Acronym / sponsor ID
- NoHarm / NoHarm1
- Conditions
- Prostatic Cancer
- Keywords
- Prostatic cancer, Radiotherapy, Hyaluronic acid
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Anders WidmarkUniversity, hospital or other
- Collaborators
- University Hospital, Umeå
- Study start
- Jan 2010
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2021 (estimated)
- First posted
- 8 Feb 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.
The dominating problem after local radiotherapy of prostate cancer is rectal toxicity. If the rectum could be completely moved out of the treated volume, a substantial decrease of rectal toxicity seems reasonable. In this study we will develop and evaluate a new transrectal injection technique where hyaluronic acid (HA) is injected in the space between the prostate and the rectum prior to external beam radiotherapy to increase the physical distance between prostate and rectum.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid | Experimental | Device: Hyaluronic acidHyaluronic acid will be injected in the space between the prostate and rectum prior to radiotherapy to perform a dorsal movement of rectum. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically verified prostatic cancer
- Low or intermediate risk prostatic cancer
- Lymph node negative
- Suitable for radiotherapy
Key exclusion criteria (2 listed)
- Earlier treatment for prostatic cancer
- Unable to co-operate or suffering from any other form of disease that would interfere with the planned treatment
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 |
|---|---|---|
| Hyaluronic acidAlso: NASHA Spacer GelInjection in connection with ultrasound | Device | Hyaluronic acid |
Primary outcome
Remaining volume of HA
Time frame: 24 month after end of radiotherapy
Measurement on the remaining volume of HA by MRI
1 secondary outcome
Quality of life
Time frame: 24 month after end of radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
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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.
Anders Widmark, Prof MD principal investigator
Umea university, dept of oncology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hyaluronic acid in people with Prostatic Cancer, run by Anders Widmark at 3 sites in Sweden.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Remaining volume of HA (time frame: 24 month after end of radiotherapy). 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 4 Nov 2016.