Prostate CancerPhase 1NCT00882232
Cross-linked Hyaluronan Gel Reduces Rectal Toxicity Due to Radiation Therapy for Prostate Cancer
A Phase 1 study testing Cross-linked hyaluronan gel in people with Prostate Cancer, run by Cancer Center of Irvine at 1 site in United States.
Trial summary
The primary purpose of this study is to determine if cross-linked hyaluronan gel reduces the dose of radiation delivered to the rectum and the rectal toxicity of radiotherapy for localized prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Cross-linked hyaluronan gel
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Sep 2009
- Phase
- Phase 1
- 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
Who may be able to join
- Histologically-confirmed adenocarcinoma of the prostate, clinical stage T1c-T2c, NX, N0, M0.
- Nodes determined to be negative by imaging methods will be classified as NX. Only nodes determined to be negative by surgical sampling will be classified as N0.
- Prostate cancer biopsy grading by Gleason score classification is mandatory.
- No prior pelvic radiotherapy. Induction hormonal therapy for less than or equal to 6 months is acceptable.
- Prostate volume by TRUS < 50 cc prior to HDR brachytherapy.
- Prostate specific antigen (PSA) less than or equal to 30 ng/ml.
- Patient has provided informed consent.
Who cannot join
- Clinical stage T3 or T4.
- Clinical evidence of lymph node involvement (N1).
- Clinical evidence of distant metastases (M1).
- Radical surgery for carcinoma of the prostate.
- Allergy to avian products.
- Significant mental, medical, or physical impairment.
- Prisoners.
- Employees of the Cancer Center of Irvine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transperineal Injection of Cross-linked Hyaluronan Gel Into Anterior Perirectal Fat to Reduce Rectal Toxicity From High Dose Rate Brachytherapy and/or Intensity-Modulated Radiation Therapy for Prostate Cancer
The primary purpose of this study is to determine if cross-linked hyaluronan gel reduces the dose of radiation delivered to the rectum and the rectal toxicity of radiotherapy for localized prostate cancer.
Read the detailed description
The main risk associated with transperineal injection of cross-linked hyaluronan gel into the anterior perirectal fat is infection. Prophylactic antibiotics will be given, resulting in a <5% risk. Another possible risk (<5%) is an allergic reaction such as itching. Patients who are allergic to avian products will be excluded from the study. Tenderness and pain at the injection site are possible. Bleeding, bruising, redness, or discoloration or the formation of a bump (granuloma) or scar (keloid) at the injection site is also possible. Embolization of cross-linked hyaluronan gel through the blood is a potential, rare complication if the gel is injected into a blood vessel rather than into fat. Prada et al. did not see any side effects related to the injection or the material itself in 27 patients based on a mean follow-up of 13 months (range: 9-22 months). Patients did not complain of pain, tenesmus, rectal pressure, or a sensation of rectal filling. Risks beyond 22 months are not well defined. Potential benefits of cross-linked hyaluronan gel include fewer rectal complications due to radiotherapy for early-stage prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- Cross-linked hyaluronan gel
- Keywords
- prostate, cancer, cross-linked, hyaluronan, gel, Hylaform, rectal, toxicity
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-linked hyaluronan gelDevice
Also called Hylaform
Single, transperitoneal injection of 9 mL cross-linked hyaluronan gel into anterior perirectal fat under anesthesia. The gel is injected prior to the start of radiotherapy and is absorbed by the body over several months. It increases the seapartion between the prostate and rectum by 1/3" to 2/3" at the start of radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cross-linked hyaluronan gel and radiotherapy. Cross-linked hyaluronan gel is injected under anesthesia between the prostate and rectum prior to the start of radiotherapy. The gel pushes the prostate away from the rectum over several months, thereby reducing the dose of radiation delivered to the rectum. Hyaluronic acid is a naturally-occurring substance that is gradually absorbed by the body. Receives: Device: Cross-linked hyaluronan gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean rectal dose without Hylaform vs with Hylaform
Measured: 8 months
Secondary outcomes (3)
Severity of late diarrhea without Hylaform vs with Hylaform
Measured: 33 months
Rectal wall relative V60 and V70 without Hylaform vs with Hylaform
Measured: 8 months
Severity of acute diarrhea during IMRT without Hylaform vs with Hylaform
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2009 (estimated)
- Study startSep 2008
- Primary completionSep 2009
- Study completionSep 2009
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Center of Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- Kenneth M Tokita, MD, Principal investigator, Cancer Center of IrvineRichard B Wilder, MD, Study director, Cancer Center of Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882232
- Sponsor's protocol ID
- G080064
- Other IDs
- S002
- Status last verified
- Feb 2013
- First submitted
- 15 Apr 2009
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transperineal Injection of Cross-linked Hyaluronan Gel Into Anterior Perirectal Fat to Reduce Rectal Toxicity From High Dose Rate Brachytherapy and/or Intensity-Modulated Radiation Therapy for Prostate Cancer
- ClinicalTrials.gov ID
- NCT00882232
- Acronym / sponsor ID
- G080064
- Conditions
- Prostate Cancer
- Keywords
- prostate, cancer, cross-linked, hyaluronan, gel, Hylaform, rectal, toxicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cancer Center of IrvineUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- Sep 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 16 Apr 2009 (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 primary purpose of this study is to determine if cross-linked hyaluronan gel reduces the dose of radiation delivered to the rectum and the rectal toxicity of radiotherapy for localized prostate cancer.
Detailed description
The main risk associated with transperineal injection of cross-linked hyaluronan gel into the anterior perirectal fat is infection. Prophylactic antibiotics will be given, resulting in a <5% risk. Another possible risk (<5%) is an allergic reaction such as itching. Patients who are allergic to avian products will be excluded from the study. Tenderness and pain at the injection site are possible. Bleeding, bruising, redness, or discoloration or the formation of a bump (granuloma) or scar (keloid) at the injection site is also possible. Embolization of cross-linked hyaluronan gel through the blood is a potential, rare complication if the gel is injected into a blood vessel rather than into fat. Prada et al. did not see any side effects related to the injection or the material itself in 27 patients based on a mean follow-up of 13 months (range: 9-22 months). Patients did not complain of pain, tenesmus, rectal pressure, or a sensation of rectal filling. Risks beyond 22 months are not well defined. Potential benefits of cross-linked hyaluronan gel include fewer rectal complications due to radiotherapy for early-stage prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Cross-linked hyaluronan gelCross-linked hyaluronan gel and radiotherapy. Cross-linked hyaluronan gel is injected under anesthesia between the prostate and rectum prior to the start of radiotherapy. The gel pushes the prostate away from the rectum over several months, thereby reducing the dose of radiation delivered to the rectum. Hyaluronic acid is a naturally-occurring substance that is gradually absorbed by the body. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically-confirmed adenocarcinoma of the prostate, clinical stage T1c-T2c, NX, N0, M0.
- Nodes determined to be negative by imaging methods will be classified as NX. Only nodes determined to be negative by surgical sampling will be classified as N0.
- Prostate cancer biopsy grading by Gleason score classification is mandatory.
- No prior pelvic radiotherapy. Induction hormonal therapy for less than or equal to 6 months is acceptable.
- Prostate volume by TRUS < 50 cc prior to HDR brachytherapy.
Key exclusion criteria (8 listed)
- Clinical stage T3 or T4.
- Clinical evidence of lymph node involvement (N1).
- Clinical evidence of distant metastases (M1).
- Radical surgery for carcinoma of the prostate.
- Allergy to avian products.
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 |
|---|---|---|
| Cross-linked hyaluronan gelAlso: HylaformSingle, transperitoneal injection of 9 mL cross-linked hyaluronan gel into anterior perirectal fat under anesthesia. The gel is injected prior to the start of radiotherapy and is absorbed by the body over several months. It increases the seapartion between the prostate and rectum by 1/3" to 2/3" at the start of radiotherapy. | Device | 1 |
Primary outcome
Mean rectal dose without Hylaform vs with Hylaform
Time frame: 8 months
3 secondary outcomes
Severity of late diarrhea without Hylaform vs with Hylaform
Time frame: 33 months
Rectal wall relative V60 and V70 without Hylaform vs with Hylaform
Time frame: 8 months
Severity of acute diarrhea during IMRT without Hylaform vs with Hylaform
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
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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.
Kenneth M Tokita, MD principal investigator
Cancer Center of Irvine
Richard B Wilder, MD study director
Cancer Center of Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cross-linked hyaluronan gel in people with Prostate Cancer, run by Cancer Center of Irvine at 1 site in United States.
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 8 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: finished, as of the sponsor's last update on 15 Feb 2013. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean rectal dose without Hylaform vs with Hylaform (time frame: 8 months). 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 15 Feb 2013.