Protocol Number: FE200486 CS37, Sponsor: Ferring Pharmaceuticals
 
  Eligibility
Criteria for participation:
  • Rising PSA after having undergone primary therapy
  • Histologically confirmed (Gleason graded) adenocarcinoma of the prostate (non-metastatic)
  • Men 18 years of age or older
  • A life expectancy of at least fifteen months
  • Documented absence of visceral or bony metastasis evidenced by CT scan, MRI scan, or bone scan within the last six months
  • No adjuvant hormone therapy twelve months prior to randomization
  • No history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema
  • No previous history or presence of another malignancy, other than prostate cancer or treated squamous / basal cell carcinoma of the skin, within the last five years
  • No clinically significant disorder (other than prostate cancer) including, but not limited to, renal, hematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, which may affect the patient’s health or the outcome of the trial
  • Not part of an ongoing clinical trial

Duration of Study
Study period will be approximately 14 months.

Clinical Research Coordinators:
Patricia Edwards, RN (336) 274-1114 ext. 5322
Karen Michael, RN (336) 274-1114 ext. 5328
E-mail address: research@allianceurology.com



Printable View