Randomized AmnioFix Study During Radical Prostatectomy

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.

Inclusion Criteria:

1. Male subjects between the ages 35-75

2. Primary diagnosis of prostate cancer selected for surgical intervention by one of the
six protocol surgeons (Chapin, Davis, Matin, Pettaway, Pisters, Ward).

3. Have a willingness to comply with follow-up HRQOL (health related quality of life)
surveys and PSA assessments.

4. Have ability to provide full written consent.

5. Primary diagnosis of untreated with clinically localized prostate cancer with Gleason
score of 6, 7,8 or 9.

6. Planned elective radical prostatectomy with bilateral nerve sparing technique that
can include high or low fascia.

7. Negative urinalysis within 30 days prior to date of surgery

Exclusion Criteria:

1. High-risk cancer planned for neoadjuvant therapy, full or partial excision of one or
both neurovascular bundles.

2. 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.

3. Is unable to comply with learning and documenting penile rehabilitation, including
oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable
medications.

4. In the opinion of the PI, has a history of drug or alcohol abuse within last 12
months.

5. Is allergic to Aminoglycoside antibiotics (such as Gentamicin and/or Streptomycin).

6. 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.

7. 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.

8. Has had prior hormonal therapy such as Lupron or oral anti-androgens.

9. Unwilling to participate in follow-up clinical appointments at MDACC.