FERRING 000108

Study StatusEnrolling
Protocol000108
SponsorFerring Pharmaceuticals
Study Description

A Multi-Center, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Major Adverse Cardiovascular Events in Patients with Prostate Cancer and Cardiovascular Disease Receiving Degarelix (GnRG Receptor Antagonist) or Leuprolide (GnRH Receptor Agonist)

Primary Endpoint

Demonstrate that a (GnRH) receptor antagonist (Degarelix) can reduce the risk of major adverse cardiovascular events as compared to a GnRH receptor agonist (Leuprolide) in patients with prostate cancer and concomitant cardiovascular disease

Inclusion Criteria

-Signed ICF obtained before any trial related activity is performed
-Histologically confirmed adenocarcinoma of the prostate
-Clinical tumor staging (Tumor, Nodule and Metastasis available prior to treatment start, radiographic imaging) should have been done within 3 months prior to treatment start. If no radiographic imaging is available at the time of screening, a bone scan should be performed.

-Investigator judgement indication to initiate continued ADT with an intended treatment duration of 12 months or longer. Patients should satisfy one of the following disease categories:
       -Advanced prostate cancer-patients without earlier prostate cancer treatment
        and who are not considered candidates for local therapy of curative intent
              -Locally advanced prostate cancer with high/unfavorable risk criteria at
                the time of enrollment
              -Metastatic prostate cancer
      -Post-radiation therapy recurrence defined by: PSA rise by 2 ng/mL or more
       above the nadir PSA on 2 consecutive determinations at least two weeks apart
              -Non-metastatic post-radiation therapy patients with recurrence who are
               not candidates for additional local therapy and who satisfy the high/
               unfavorable risk criteria at the time of definitive radiotherapy, or with a
               PSA doubling time <10 months
             -Metastatic post-radiation therapy patients
-Patients must be treatment naïve with regard to ADT at time of randomization (with the exception of neoadjuvant/adjuvant hormonal therapy for a maximum duration of 6 months-in this case treatment has to be terminated at least 12 months prior to randomization)
-Patients must have a screening serum testosterone level above the lower limit of normal range, defined as > 150 ng/dL (5.2nmol/L)
-Pre-existing CVD (confirmed diagnosis prior to randomization ) according to at least one of the following criteria:
       -Spontaneous MI from 30 days to 5 years prior to randomization
       -Coronary revascularization (PCI or multivessel CABG) from 30 days to 5 years
        prior to randomization
       -Carotid artery or iliofemoral artery revascularization from 30 days to 5 years
        prior to randomization (percutaneous or surgical procedures)
       -Prior coronary, peripheral or carotid angiogram/CT angiogram; or a prior
        carotid doppler ultrasound at any time point before randomization;
        documenting at least one stenosis ≥70%
       -Significant stenosis of peripheral arteries determined by a documented
        resting ankle-brachial pressure index < 0.9 at any time point before
        randomization

Exclusion Criteria

-Previous or current hormonal management of prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens, megestrol acetate, ketoconazole, abieraterone and enzalutamide); except neoadjuvant/adjuvant hormonal therapy for a maximum duration of 6 months (in this case tx has to be terminated at least 12 months prior to randomization).
-Patients who are considered to be candidates for therapy with curative intention (radical prostatectomy, cryotherapy or radiotherapy) or those in need of neoadjuvant hormonal therapy.
-Patients who are candidates for hormonal therapy due to rising PSA after therapy with curative intention with an expected intended duration of ADT potentially of less than 12 months.
-Current use of an oral anti-coagulant for thromboembolic stroke prevention in patients with a fib or flutter
-Hypersensitivity toward any component of the IMPs or excipients.
-Uncontrolled type 1 or type 2 DM (hgb A1C > 10 %)
-Uncontrolled HTN at time of randomization (>180 systolic >110 diastolic)
-MI, stroke, coronary, carotid, or peripheral artery revascularization within 30 days prior to randomization
-Planned or scheduled cardiac surgery or PCI procedure that is known at the time of randomization
-Other clinically significant disorder including renal, hematological, GI, endocrine, neurological, or psychiatric disease, and alcohol or drug abuse
-Mental incapacity of language barrier
-Tx with an investigational drug within the last month prior to randomization

Side Effects

Leuprolide:
Hot flashes, pain, joint pain, upset stomach, trouble urinating, weakness, depression, headache, change in breast size, edema, dizziness, muscle pain

Degarelix:
Fatigue, chills or hot flashes, weight gain, abnormal liver function tests, joint pain, back pain, increased BP

Interested in enrolling in this trial? Please call 717-431-2285.


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