Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT00600691 |
| Other study ID # |
H07-01188 |
| Secondary ID |
Health Canada Co |
| Status |
Terminated |
| Phase |
Phase 2
|
| First received |
January 14, 2008 |
| Last updated |
January 29, 2014 |
| Start date |
March 2008 |
| Est. completion date |
December 2011 |
Study information
| Verified date |
January 2014 |
| Source |
University of British Columbia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Canada: Health Canada |
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of our study is primarily to evaluate the effects of 5mg finasteride on
hematuria and hematospermia commonly associated with prostate biopsies. We hypothesize that
5mg of finasteride daily for two weeks preceding TRUS prostate biopsy and one week following
will reduce hematuria and hematospermia commonly seen as complications following prostate
biopsy. We also hypothesize that reducing complications will decrease concern among subjects
and make for a more tolerable overall procedure than compared with subjects treated with
placebo.
Description:
Study Purpose:
The purpose of our study is primarily to evaluate the effects of 5mg finasteride on
hematuria and hematospermia commonly associated with prostate biopsies. We will also examine
how effective the dosing of finasteride administered two weeks prior to biopsy and one week
following. We will also use the subject questionnaire to assess subject's attitudes and
concerns about hematuria and hematospermia. We will examine the overall subjective
tolerability of the biopsy procedure, concerns about sexual function, anxiety surrounding
prostate cancer, and urination following the procedure. Questionnaires will use a 10 point
visual analog scale to gauge subject's attitudes and concerns. We will examine for any
statistically significant correlations between these parameters and the complications we are
monitoring. We will also monitor side effects of subjects, in an effort to gauge the
potential risks associated with short term usage of finasteride compared to any benefits
afforded by finasteride on reducing hematuria and hematospermia.
Hypotheses:
Based on the previous research into the molecular mechanisms of finasteride, we hypothesize
that 5mg of finasteride daily for two weeks preceding TRUS prostate biopsy and one week
following will reduce hematuria and hematospermia commonly seen as complications following
prostate biopsy. We also hypothesize that reducing complications will decrease concern among
subjects and make for a more tolerable overall procedure than compared with subjects treated
with placebo.
Objectives:
To determine the effectiveness of 5mg finasteride administered two weeks prior to prostate
biopsy and one week following on reducing hematuria and hematospermia following biopsy.
To gauge subject's concerns relating to hematuria, hematospermia, and transmitting prostate
cancer to partners following TRUS prostate biopsy.
To examine subject's subjective sexual function and urination in relation to their treatment
group.
To demonstrate benefits of finasteride in relation to the safety and tolerability of
treatment.
Endpoints:
Differences in rate and severity of hematuria and hematospermia among subjects in treatment
and placebo groups.
Differences in complications following biopsies, such as hospitalization and requirement for
blood transfusion, between treatment and placebo groups.
Differences between placebo group and finasteride treatment group in: overall subjective
experience of biopsy procedure, concern relating to hematuria and hematospermia, sexual
function, and urination following prostate biopsy.
Monitor side effects between placebo and finasteride when administered for three weeks total
duration.
Research design:
The study we plan to conduct will be a randomized, double-blind, placebo controlled study to
determine the effects of 5mg finasteride on the rate/severity of hematuria and hematospermia
following TRUS prostate biopsy.
A total of 50 subjects will be randomized into one of two groups. One group will receive 5mg
of finasteride orally for two weeks prior to TRUS biopsy, and one week after the biopsy.
Another group will receive a placebo orally for two weeks prior to the procedure and one
week following the biopsy. Patients will be identified for participation by existing
indication for TRUS prostate biopsy, and subsequently enrolled. Subjects will receive the
current standard of care in addition to participating in this study.
The study is designed to investigate the effects of finasteride compared to placebo on
hematuria and hematospermia following prostate biopsy. Subjects will be assigned to
treatment groups using a randomization process to eliminate selection bias, and to ensure
that any differences between the two study groups are due to random chance. The study has
been designed as placebo controlled and double blinded to ensure that investigator and
subject ascertainment biases are minimized. As there is no current prophylactic or other
treatment to decrease the rate/severity of hematuria and hematospermia following prostate
biopsies, this does not raise any ethical concerns in the placebo group.
Subject recruitment will be done on an ongoing basis.
Statistical analysis plan:
We will perform statistical analysis on the data collected from this study. We will examine
whether there is a statistically significant difference in the rates of hematuria and
hematospermia between placebo and finasteride treatment groups. We will also examine for any
statistically significant relationships between study groups (placebo versus finasteride)
and concern regarding hematuria/hematospermia, satisfaction with/tolerability of the biopsy,
concern with prostate cancer transmission, sexual/urinary function, and side effects.
Research Procedures:
Subjects will be identified as potential participants for this study in the office of Dr.
Pommerville. Dr. Pommerville will identify subjects from within his urology practice as
needing a TRUS biopsy out of medical necessity for reasons unrelated to enrollment in this
study. The indications for prostate biopsy are usually based on clinical suspicion using a
combination of digital rectal examination and prostate specific antigen blood testing. Once
identified as potential candidates for participation in this study, Dr. Pommerville will
give the potential subject a detailed explanation of the study and will explain the content
in the informed consent form. Once the patient has read the consent form and understands
what the study entails, they will make a decision whether or not to enroll in this study.
Once informed consent has been obtained, subjects will be assigned a unique identification
number, which will not be used for any other purposes. This identification code will have
features that allow the code to be broken in an emergency situation. At this time, subjects
will be randomly assigned to the placebo or treatments groups in a double blind fashion.
Subjects will be given a three week supply of 5mg of finasteride or placebo and detailed
instructions on how they are to take their medication/placebo. They will be instructed to
take their medication/placebo, one tablet (5mg) of finasteride/placebo orally each day for
two weeks prior to biopsy and one week following. This will be in addition to the standard
of care that is normally given with prostate biopsy (antibiotics, enema). They will be given
an appointment to undergo prostate biopsy in two weeks. Subjects will be instructed that if
they decide to withdraw from this study, they may do so at any time, and return the unused
medication to Dr. Pommerville's office at follow up
Subjects will then undergo TRUS prostate biopsy two weeks later as part of their standard
medical care at either the Royal Jubilee Hospital or Victoria General Hospital. Equipment
and procedures will not differ between these sites. Patients will be followed up at this
point by Dr. Pommerville on their participation and adherence to study protocol. If subjects
have not been compliant with the protocol, they will be withdrawn from the study. Subjects
will receive repeat instructions on taking their medication and released as would be
expected as part of the standard of care for prostate biopsies. They will be given an
appointment for two weeks from the TRUS biopsy to see Dr. Pommerville in his clinic. They
will be reminded to come to the clinic approximately 20 minutes prior to their appointment
time so that Nathan Hoag (Medical student) may administer a questionnaire in accordance with
what was described to them by the informed consent form.
Subjects will present for their scheduled two week follow up appointment to Dr.
Pommerville's office. This practice is in accordance with the normal standard of care.
Nathan Hoag will administer the subject questionnaire at this point. Questionnaires will be
administered prior to subjects seeing Dr. Pommerville for biopsy results in an effort to
minimize emotional influence on the results of the questionnaire. This is the last visit in
the standard medical care for prostate biopsy. Subjects are instructed to follow up with Dr.
Pommerville or their family physicians should they have additional concerns. At this time,
subjects will be reminded that they are to return to Dr. Pommerville's office in an
additional two weeks, where the medical student will administer the questionnaire for a
second time to monitor any ongoing changes (4 weeks since procedure).
In addition to the patient questionnaire, previously described grading systems will be used
to quantify the incidence and severity of hematuria and hematospermia among subjects at two
and four weeks.18,19 Hematospermia grading systems quantify hematospermia as mild (less than
7 days), moderate (7 to 14 days), and severe (more than 14 days). Hematuria is defined as
grossly passing blood or blood clots in the urine. Hematuria is stratified using minor
episodes (lasting 24 hours or less), moderate episodes (lasting more than 24 hours, but not
requiring hospital admission), and severe episodes (clot retention and hospital admission).
Hematuria will then be graded according to the following system: grade 0 (no gross
hematuria), grade 1 (up to 2 minor episodes or 1 moderate episode), grade 2 (more than 2
minor episodes or 1 moderate episode), grade 3 (1 or more severe episodes).
This will be the conclusion of the study for subjects. They will be reminded that they are
free to contact Nathan Hoag should they have any concerns or questions. They will also be
reminded that they may follow up with Dr. Pommerville or their family physicians should they
need to.
