Prostate CancerPhase 2RPAH1NCT02165020
Hyaluronic Acid for Hypofractionated Prostate Radiotherapy
A Phase 2 study testing Hyaluronic acid (Macrolane VRF 30®, Q-MED) in people with Prostate Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The present Phase II study aims to assess the rates of late rectal toxicities of grade ≥ 2 after hypofractionated radiotherapy of prostate cancer of 62 Gy in 20 fractions of 3.1 Gy with an injection of hyaluronic acid (HA) in the space between the rectum and the prostate. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Hyaluronic acid (Macrolane VRF 30®, Q-MED)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2010to May 2017
- Phase
- Phase 2
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age superior or equal to 18 years and inferior to 80 years.
- patient with a low- to intermediate-risk prostate cancer, according to D'Amico classification, for an exclusive irradiation.
- prostate cancer histologically proven.
- life expectancy superior to 10 years.
- Karnofsky performance status ≥ 60% (performance status ECOG 0-2).
- the patient has to be the beneficiary of a social security system or other insurance (order n° 2006-477 from April 26th 2006).
- the signed consent form.
Who cannot join
- age inferior to 18 years and ≥ 80 years;
- history of rectal surgery;
- patient who can't cooperate during the treatment;
- history of pelvic irradiation;
- history of inflammatory bowel disorder such as ulcerative colitis or the Crohn's disease;
- other current neoplasia or history of neoplasia dating from less than 5 months, excepting basal-cell carcinomas;
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- patients treated with anti-neoplastic or anti-angiogenic or with other treatments used in rheumatology and which may include methotrexate (in order not to have a radiosensitizing effect);
- patients receiving anticoagulant treatment or PLAVIX;
- other undergoing study that may interfere with the present study;
- patient under legal protection measure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypofractionated Radiotherapy for Prostate Cancer (62 Gy in 20 Fractions of 3.1 Gy) With Hyaluronic Acid Injection
The present Phase II study aims to assess the rates of late rectal toxicities of grade ≥ 2 after hypofractionated radiotherapy of prostate cancer of 62 Gy in 20 fractions of 3.1 Gy with an injection of hyaluronic acid (HA) in the space between the rectum and the prostate. Thirty-six patients with a low- to intermediate-risk prostate cancer according to the D'Amico classification are included in the present protocol. The main characteristics of the study are that the patients benefit of a reduction of the treatment duration from 40 to 20 fractions, due to the hypofractionated irradiation, and of an injection of 3 to 10 cc of hyaluronic acid in the perirectal fat between the rectum and the prostate.
- Conditions
- Prostate Cancer
- Being tested
- Hyaluronic acid (Macrolane VRF 30®, Q-MED)
- Keywords
- Prostate, Hypofractionated radiotherapy, Hyaluronic acid, Spacer, Rectum toxicity, Rectal toxicities after hypofractionated irradiation and injection of hyaluronic acid in patients with low- to intermediate-risk Prostate Cancer
- 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 acid (Macrolane VRF 30®, Q-MED)Device
One injection of 3 to 10 cc of hyaluronic acid (Macrolane VRF 30®, Q-MED) introduced in the perirectal fat between the rectum and the prostate in connection with an ultrasound.
The injection is performed under local anesthesia (with "Lidocaine") and ultrasound guidance, using a 16 gauge needle.
| Study group | Role | What they receive |
|---|---|---|
| Rectal toxicities after prostate hypofractionated radiotherapy | Experimental | Rectal toxicities after prostate hypofractionated radiotherapy with hyaluronic acid Receives: Device: Hyaluronic acid (Macrolane VRF 30®, Q-MED) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with late rectal toxicities (> 3 months) of grade ≥ 2 after hypofractionated radiotherapy of prostate cancer of 62 Gy in 20 fractions of 3.1 Gy with an injection of hyaluronic acid (HA) in the space between the rectum and the prostate.
Late rectal toxicities of grade ≥ 2 assessed using the CTCAE v 4.0 classification from 3 months to 3 years.
Measured: Follow-up at 3 months and 6 months after the radiotherapy and then every 6 months up to 3 years.
Secondary outcomes (4)
Number of patients with acute rectal toxicities of all grades and of grade ≥ 2.
Number of patients with acute rectal toxicities of all grades and of grade ≥ 2 (using the CTCAE v 4.0), as a measure of safety and tolerability.
Measured: 3 years
Tolerance of the HA injection
The evaluation of the tolerance of the HA injection, as a measure of safety and tolerability (using the CTCAE v 4.0).
Measured: 3 years
Number of patients with acute and late toxicities, other than the rectal toxicities.
Number of patients with acute and late toxicities (using the CTCAE v 4.0), other than the rectal toxicities, as a measure of safety and tolerability.
Measured: 3 years
The evaluation of the biochemical control
Measured: 3 years: evaluation at 3 months, 6 months and then every 6 months during the 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startNov 2010
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165020
- Sponsor's protocol ID
- 2010-606
- Acronym
- RPAH1
- Status last verified
- Oct 2016
- First submitted
- 5 May 2014
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Radiotherapy for Prostate Cancer (62 Gy in 20 Fractions of 3.1 Gy) With Hyaluronic Acid Injection
- ClinicalTrials.gov ID
- NCT02165020
- Acronym / sponsor ID
- RPAH1 / 2010-606
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Hypofractionated radiotherapy, Hyaluronic acid, Spacer, Rectum toxicity, Rectal toxicities after hypofractionated irradiation and injection of hyaluronic acid in patients with low- to intermediate-risk Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 17 Jun 2014 (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 present Phase II study aims to assess the rates of late rectal toxicities of grade ≥ 2 after hypofractionated radiotherapy of prostate cancer of 62 Gy in 20 fractions of 3.1 Gy with an injection of hyaluronic acid (HA) in the space between the rectum and the prostate. Thirty-six patients with a low- to intermediate-risk prostate cancer according to the D'Amico classification are included in the present protocol. The main characteristics of the study are that the patients benefit of a reduction of the treatment duration from 40 to 20 fractions, due to the hypofractionated irradiation, and of an injection of 3 to 10 cc of hyaluronic acid in the perirectal fat between the rectum and the prostate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rectal toxicities after prostate hypofractionated radiotherapy | Experimental | Device: Hyaluronic acid (Macrolane VRF 30®, Q-MED)Rectal toxicities after prostate hypofractionated radiotherapy with hyaluronic acid |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age superior or equal to 18 years and inferior to 80 years.
- patient with a low- to intermediate-risk prostate cancer, according to D'Amico classification, for an exclusive irradiation.
- prostate cancer histologically proven.
- life expectancy superior to 10 years.
- Karnofsky performance status ≥ 60% (performance status ECOG 0-2).
Key exclusion criteria (10 listed)
- age inferior to 18 years and ≥ 80 years;
- history of rectal surgery;
- patient who can't cooperate during the treatment;
- history of pelvic irradiation;
- history of inflammatory bowel disorder such as ulcerative colitis or the Crohn's disease;
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 acid (Macrolane VRF 30®, Q-MED)One injection of 3 to 10 cc of hyaluronic acid (Macrolane VRF 30®, Q-MED) introduced in the perirectal fat between the rectum and the prostate in connection with an ultrasound. The injection is performed under local anesthesia (with "Lidocaine") and ultrasound guidance, using a 16 gauge needle. | Device | Rectal toxicities after prostate hypofractionated radiotherapy |
Primary outcome
Number of patients with late rectal toxicities (> 3 months) of grade ≥ 2 after hypofractionated radiotherapy of prostate cancer of 62 Gy in 20 fractions of 3.1 Gy with an injection of hyaluronic acid (HA) in the space between the rectum and the prostate.
Time frame: Follow-up at 3 months and 6 months after the radiotherapy and then every 6 months up to 3 years.
Late rectal toxicities of grade ≥ 2 assessed using the CTCAE v 4.0 classification from 3 months to 3 years.
4 secondary outcomes
Number of patients with acute rectal toxicities of all grades and of grade ≥ 2.
Time frame: 3 years
Tolerance of the HA injection
Time frame: 3 years
Number of patients with acute and late toxicities, other than the rectal toxicities.
Time frame: 3 years
The evaluation of the biochemical control
Time frame: 3 years: evaluation at 3 months, 6 months and then every 6 months during the 3 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyaluronic acid (Macrolane VRF 30®, Q-MED) in people with Prostate Cancer, run by Hospices Civils de Lyon at 1 site in France.
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 7 inclusion and 10 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 5 Oct 2016. 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 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.
What does this 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.
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?
Number of patients with late rectal toxicities (> 3 months) of grade ≥ 2 after hypofractionated radiotherapy of prostate cancer of 62 Gy in 20 fractions of 3.1 Gy with an injection of hyaluronic acid (HA) in the space between the rectum and the prostate. (time frame: Follow-up at 3 months and 6 months after the radiotherapy and then every 6 months up to 3 years.). 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 5 Oct 2016.