Boca Raton Regional Hospital | Lynn Clinical Research Center
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About
The purpose of this study is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy treatment versus using docetaxel alone. Earlier studies helped show that the combination is safe, but the combination has not been proven to work better than either drug alone. The goal of this study is to find out if combining docetaxel and radium-223 is better than giving either drug by itself.
Enrollment
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Inclusion criteria
NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
Males 18 years of age and above
Histological or cytological proof of prostate cancer
Documented progressive mCRPC based on at least one of the following criteria:
Two or more bone lesions
ECOG 0- 1
Normal organ function with acceptable initial laboratory values within 14 days of randomization:
Subjects must agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 30 days after the last dose of study drug. Sperm donation is prohibited during the study and for 30 days after the last dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.
Serum testosterone < 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH analogue (agonist or antagonist) if they have not undergone orchiectomy.
All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 Grade 1 or less.
Willing and able to comply with the protocol, including follow-up visits and examinations
Exclusion criteria
Received any other investigational therapeutic agents or other anticancer therapies within 4 weeks prior to randomization.
Received external beam radiotherapy within the 4 weeks prior to randomization.
Has an immediate need for external beam radiotherapy.
Has received any systemic bone-seeking radiopharmaceutical in the past.
Has received any prostate cancer directed chemotherapy in the castration resistant setting. Subjects who have received up to 6 prior doses of docetaxel in the castration sensitive setting are permitted if they have not experienced disease progression within 36 weeks of last treatment with docetaxel.
Has received four or more systemic anticancer regimens for mCRPC.
Has known Grade ≥3 docetaxel-related toxicities or docetaxel toxicity related dose interruption or discontinuation.
Has received blood transfusions or growth factors within the last 4 weeks prior to randomization.
Symptomatic nodal disease (i.e., scrotal, penile, or leg edema).
Has visceral metastases with ≥ 3 lung and/or liver metastases or individual lesion ≥2 cm, as assessed by CT scan or MRI of the chest/abdomen/pelvis within the last 8 weeks prior to randomization.
Symptomatic loco-regional disease that causes ongoing Grade 3 or Grade 4 urinary or rectal symptoms.
Subjects with a "currently active" second malignancy other than non-melanoma skin cancers or non-invasive bladder cancers or other in-situ or non-invasive malignancies. Subjects are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 3 years.
Has imminent or established cord compression based on clinical findings and/or MRI.
Known bone marrow dysplasia
Has received any of the following in the 4 weeks prior to randomization: 5-alpha-reductase inhibitors, herbal medications, natural hormonally active foods (e.g., phytoestrogens) or other food supplements known to alter PSA in humans
Any other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous, including but not limited to:
Primary purpose
Allocation
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Masking
738 participants in 2 patient groups
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Central trial contact
Michael Morris, MD; Josef Fox, MD
Data sourced from clinicaltrials.gov
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