The rationale of the study was to evaluate different degarelix dosing regimens for a
three-month interval that was to produce and maintain castration in prostate cancer patients
through immediate and prolonged testosterone suppression, and to provide confirmatory
evidence of the safety of degarelix.
The purpose of this study is to evaluate the recurrence rate of noninvasive bladder cancer
at 2 years in patients with tumor histology Ta, G1-G2 who are randomized to receive TUR-BT
plus EOquin® versus those who are randomized to receive TUR-BT plus placebo.
The primary purpose of this research is to describe patient characteristics predictive of an
imaging study positive for distant metastases in patients with castration-resistant prostate
cancer and no known distant metastases.
The purpose of this study was to see if giving Degarelix every month for 7 months then stop
treatment for 7 months (intermittent therapy) would show a reduction of negative effects of
androgen deprivation therapy by increasing the quality of life while keeping prostate
specific antigen (PSA) levels suppressed.
Benign Prostatic Hyperplasia (BPH) is the most common hyperplastic disease occuring in human
males over the age of 50 which increases in prevalence with age and 40% of males reported
moderate or severe urinary symptoms of prostatism by the age of 50 to 80. The purpose of
this study is to collect safety and efficacy data for this dosage regimen of cetrorelix
For this study, study medication (Cetrorelix pamoate) is administered by injection in the
... Read More
The purpose of this study is to determine if toremifene citrate is effective and safe in the
prevention of prostate cancer in men who have been diagnosed with high grade prostatic
intraepithelial neoplasia (PIN).
The purpose of this trial was to find an optimal dose for a new trial drug - degarelix
(FE200486) - in the treatment of prostate cancer. Furthermore the safety of the drug was
studied. Patients participating were treated with FE200486 on one occasion. Thereafter they
came in for visits following a specific schedule until blood samples showed that there was
no further effect.
Androgen deprivation therapy (ADT) treatment for prostate cancer decreases the natural
hormone called testosterone. This type of therapy is very effective for the treatment of
prostate cancer. However, one of the side effects is bone loss or thinning of the bones that
can lead to osteoporosis and an increased risk of bone fractures (breaking of the bones).
The purpose of the study is to determine whether or not the addition of toremifene citrate
(the study ... Read More
This post-marketing study is being conducted to evaluate the long-term safety and
effectiveness of the Prolieve Thermodilatation® System (Prolieve®) in the treatment of
Benign Prostatic Hyperplasia (BPH). A secondary objective is to assess the safety and
effectiveness of re-treatment with Prolieve® and determine the percent of subjects electing
to be re-treated with Prolieve® rather than alternate therapy. This study will follow
subjects treated with ... Read More
This was an extension study for the study FE200486 CS12 (NCT00819156). Each participant was
to be treated until he was discontinued or withdrawn from the study, or a marketing
authorization for degarelix had been obtained.
The study was terminated when all ongoing participants had been treated for at least 5 years
(including one year in the main study).
Praecis is currently conducting a 2000 patient Experience Study; this is a Phase IV
commitment postmarketing safety study in the Food and Drug Administration (FDA) indicated
population of patients receiving Plenaxis®. The purpose of the study is to estimate the
incidence of immediate-onset systemic allergic reactions in the indicated population
receiving Plenaxis® and to determine whether the hazard rate changes over time.
The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment of
solifenacin succinate versus placebo in participants who are incontinent after Robotic
Assisted Radical Prostatectomy.
This study will also assess the effect of 12 weeks of treatment with solifenacin succinate
versus placebo on quality of life (QOL) as measured by questionnaires.
This is an international, multicenter, double-blind, placebo-controlled, randomized study.
All eligible patients entering the open label phase of the study will receive a single
immediate instillation of apaziquone (4 mg in 40 mL diluent), post transurethral
resection-bladder tumor (TURBT). Following Central Pathology review of histology and Double
Blind Phase qualification, patients with confirmed eligibility will be randomized to receive
either 6 weekly ... Read More
A phase 3, open-label, parallel group, one year trial comparing the efficacy and safety of
degarelix 3-month depot with the established therapy goserelin acetate 3-month implant in
patients with prostate cancer.