EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer
Condition: Prostate Cancer Metastatic
MeSH terms: Prostatic Neoplasms
Intervention: EMD 525797; EMD 525797; Placebo; Standard of Care (SoC)
Intervention description: Subjects will be administered with EMD 525797 at a dose of 1500 milligram (mg) (diluted with 0.9 percent [%] sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons.; Subjects will be administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons.; Subjects will be administered with placebo (as 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons.; All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 180.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Asymptomatic; mildly symptomatic; metastatic castrate-resistant prostate cancer; mCRPC

Summary:

      The primary objective of the trial is to evaluate the clinical anti-tumor activity of EMD
      525797 administered as 1-hour intravenous infusion every 3 weeks in terms of progression free
      survival (PFS) time in subjects with asymptomatic or mildly symptomatic metastatic
      castrate-resistant prostate cancer (mCRPC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma of the prostate (Gleason
             score)

          -  Bisphosphonate treatment

          -  Stable, ongoing adequate testosterone suppression proven by hypogonadal levels of
             testosterone (less than or equal to) <= 50 nanogram per deciliter [ng/dL]) for
             subjects without surgical castration (luteinizing hormone-releasing hormone
             antagonists and agonists)

          -  Other protocol defined inclusion criteria could apply

        Exclusion Criteria:

          -  Prior chemotherapy, biologic therapy (targeted therapy), or any experimental therapy
             for mCRPC

          -  Chronic and ongoing treatment with opioids

          -  Acute pathologic fracture, spinal cord compression, or hypercalcemia at Screening

          -  Visceral metastasis, brain metastasis

          -  Radiotherapy to bone lesions and/or orthopedic surgery for pathologic fractures. Any
             kinds of major elective surgery within 30 days prior to trial treatment

          -  Other protocol defined exclusion criteria could apply