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Prostate CancerPhase 2NCT02645591

Randomized AmnioFix Study During Radical Prostatectomy

A Phase 2 study testing Robotic Assisted Laparoscopic Radical Prostatectomy (RARP), AmnioFix® and Questionnaire in people with Prostate Cancer, run by M.D. Anderson Cancer Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The goal of this clinical research study is to learn about the safety and the effectiveness of using AmnioFix® (dehydrated human amnion/chorion membrane, also called dHACM) to help improve the return of erectile function and bladder control in patients after robotic assisted laparoscopic radical prostatectomy (RARP). Read more about this study

Who is it for?
Ages 35 to 75 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Robotic Assisted Laparoscopic Radical Prostatectomy (RARP), AmnioFix® and Questionnaire
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Nov 2016to Nov 2019
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 35 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male subjects between the ages 35-75
  • Primary diagnosis of prostate cancer selected for surgical intervention by one of the six protocol surgeons (Chapin, Davis, Matin, Pettaway, Pisters, Ward).
  • Have a willingness to comply with follow-up HRQOL (health related quality of life) surveys and PSA assessments.
  • Have ability to provide full written consent.
  • Primary diagnosis of untreated with clinically localized prostate cancer with Gleason score of 6, 7,8 or 9.
  • Planned elective radical prostatectomy with bilateral nerve sparing technique that can include high or low fascia.
  • Negative urinalysis within 30 days prior to date of surgery

Who cannot join

  • High-risk cancer planned for neoadjuvant therapy, full or partial excision of one or both neurovascular bundles.
  • Has any condition(s), which seriously compromises the subject's ability to participate in this study, sign consent, or has a known history of poor adherence with medical treatment.
  • Is unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable medications.
  • In the opinion of the PI, has a history of drug or alcohol abuse within last 12 months.
  • Is allergic to Aminoglycoside antibiotics (such as Gentamicin and/or Streptomycin).
  • Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
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  • Patients currently enrolled in another study. Concurrent enrollment in another study is prohibited expect for the control arm which can be used for other protocols with HRQOL endpoints with similar instruments.
  • Has had prior hormonal therapy such as Lupron or oral anti-androgens.
  • Unwilling to participate in follow-up clinical appointments at MDACC.

About this study

Official title: Neurovascular Bundle Protection With an Amnion/Chorion Membrane Allograft to Improve Postoperative Functional Recovery: A Randomized Comparison to Standard Techniques

The goal of this clinical research study is to learn about the safety and the effectiveness of using AmnioFix® (dehydrated human amnion/chorion membrane, also called dHACM) to help improve the return of erectile function and bladder control in patients after robotic assisted laparoscopic radical prostatectomy (RARP).

dHACM is a section of tissue made from part of the placenta donated by a mother during a C-section. It looks like a small piece of tissue paper and is wrapped around the nerve bundles in the surgical area. The tissue may help the body's normal healing process.

Read the detailed description

Study Groups:

If participant is eligible and agrees to take part in the study, they will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Participant will have an equal chance of being in either group. This is done because no one knows if one study group is better, the same, or worse than the other group:

  • If participant is in Group 1, they will have RARP with dHACM.
  • If participant is in Group 2, they will have RARP alone.

Participant will not be told which group they are assigned to until they reach the end of the study. Participant will sign a separate consent form for the surgery that explains the risks.

During Surgery:

If participant is in Group 1, the dHACM will be wrapped around the nerve bundles at the end of the surgery.

For both groups, during the surgery, participant's surgeon may decide that RARP is not possible. In this case, participant will be taken off the study and dHACM will not be used.

Information will also be collected during participant's surgery, such as details about their surgery, their hospital stay, and about any side effects that they may have.

Study Visits:

Participant will visit the study doctor for their standard follow-up visits after surgery at 6 weeks, 3 months, 6 months, and 12 months. At these visits, participant will complete the same questionnaire they completed at screening.

At 24 months, participant's medical chart will be reviewed or they will be called on the phone to learn if the disease came back. If participant is called, the call should last about 5-10 minutes.

Length of Study Participation:

Patient's participation in the study will be over after the 24-month medical chart review or call.

This is an investigational study. The dHACM is commercially available for use in various types of surgeries. Its use in prostate surgery to help improve the return of erectile function and bladder control in patients after RARP is investigational.

Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.

Conditions
Prostate Cancer
Being tested
Robotic Assisted Laparoscopic Radical Prostatectomy (RARP), AmnioFix®, Questionnaire
Keywords
Prostate cancer, Dehydrated human amnion/chorion membrane, dHACM, Robotic assisted laparoscopic radical prostatectomy, RARP, AmnioFix®, Sexual function score, Neurovascular bundle inflammation, Questionnaire, Survey
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Robotic Assisted Laparoscopic Radical Prostatectomy (RARP)Procedure or surgery

    Also called RALP

    Participants receive Nerve Sparing robotic assisted laparoscopic radical prostatectomy (RARP).

  • AmnioFix®Biological

    Also called Dehydrated Human Amnion/chorion Membrane, dHACM

    Dehydrated human amnion/chorion membrane (dHACM) wrapped around the nerve bundles at the end of Nerve Sparing robotic assisted laparoscopic radical prostatectomy (RARP) surgery.

  • QuestionnaireBehavioural

    Also called Survey

    Questionnaire completed about erectile function before surgery, and at 6 weeks, 3 months, 6 months, and 12 months after surgery.

Study groups in NCT02645591
Study groupRoleWhat they receive
Nerve Sparing RARP + AmnioFix®ExperimentalParticipants receive Nerve Sparing robotic assisted laparoscopic radical prostatectomy (RARP) plus placement of a 2x12 sheet of AmnioFix® to the neurovascular bundle.
Receives: Procedure: Robotic Assisted Laparoscopic Radical Prostatectomy (RARP); Biological: AmnioFix®; Behavioral: Questionnaire
Nerve Sparing RARPActive comparatorParticipants receive Nerve Sparing robotic assisted laparoscopic radical prostatectomy (RARP)
Receives: Procedure: Robotic Assisted Laparoscopic Radical Prostatectomy (RARP); Behavioral: Questionnaire

What is being measured

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

  1. Reducing Neurovascular Bundle Inflammation in Prostate Cancer Patients Undergoing Nerve Sparing Robotic Assisted Laparoscopic Radical Prostatectomy (RARP)

    Outcome determined by a 10-point improvement in 3-month post-prostatectomy sexual function score using the Expanded Prostate Cancer Index Composite (EPIC) 26 in patients treated with the AmnioFix® graft compared to standard treatment.

    Measured: 3 months

Timeline

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

  1. First posted1 Jan 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionNov 2019 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02645591
Sponsor's protocol ID
2015-0633
Other IDs
NCI-2016-00342
Status last verified
Nov 2016
First submitted
31 Dec 2015
Last updated
22 Nov 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Robotic Assisted Laparoscopic Radical Prostatectomy (RARP), AmnioFix® and Questionnaire in people with Prostate Cancer, run by M.D. Anderson Cancer Center.

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 9 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: withdrawn, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Reducing Neurovascular Bundle Inflammation in Prostate Cancer Patients Undergoing Nerve Sparing Robotic Assisted Laparoscopic Radical Prostatectomy (RARP) (time frame: 3 months). 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 NCT02645591.

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 22 Nov 2016.

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Randomized AmnioFix Study During Radical Prostatectomy | AzTrials