10301 - A Phase I and Randomized Phase II Trial of Radium-223 dichloride M3814 & Avelumab in Advanced Metastatic Castrate-Resistant Prostate Cancer (mCRPC)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Prostate Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male
  • Other Inclusion Criteria:
    1) PHASE 1: Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%). PHASE 2: ECOG performance status =< 2 (Karnofsky >= 60%) Unless a patient has had orchiectomy by surgery, the patient is expected to be on antiandrogen therapy (ADT) for "medical castration". 2) Lymph node metastases in each individually must measure less than 3 cm in the longest dimension. 3) A diagnosis of prostate cancer must have been histologically confirmed at any time point Baseline prostatic specific antigen (PSA) level of 1 ng/mL or higher with evidence of progressively increasing PSA values.

You may not be eligible for this study if the following are true:

  • 1) Active autoimmune conditions or patients on chronic immunosuppression due to underlying autoimmune condition and patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study. 2) Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the exception of alopecia Prior therapy with radionuclides (e.g., strontium, samarium, rhenium, radium). 3) Patients who are receiving any other investigational agents. 4) Patients who have had previous hemibody external radiation.


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