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Active Not Recruiting
NCT00859781
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer
Conditions: Prostate Cancer
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 55
Sponsor: Weill Medical College of Cornell University
Location: Cedars Sinai Los Angeles California
Summary
The purpose of this study is to test the effectiveness of the experimental drug, 177Lu-J591 in combination with ketoconazole and hydrocortisone against prostate cancer.
Eligibility Criteria
Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the prostate previously treated with surgery and/or radiotherapy.
* Biochemical progression (rising PSA) after medical or surgical castration
* High risk of systemic progression defined as:
1. Rising PSA as defined above and either:
2. Absolute PSA \> 20 ng/mL AND/OR
3. PSA doubling time \< 8 months
* No evidence of local recurrence or distant metastases
* Age \>18 years.
* Serum testosterone \< 50 ng/ml
* Patients capable of fathering children must agree to use an effective method of contraception for the duration of the trial.
* Subjects on bisphosphonate therapy must be on a stable dose and must have started therapy \> 4 weeks prior to protocol therapy.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Use of red blood cell or platelet transfusions within 4 weeks of treatment
* Use of hematopoietic growth factors within 4 weeks of treatment
* Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment
* Prior radiation therapy encompassing \>25% of skeleton (see Appendix C)
* Prior treatment with 89Strontium or 153Samarium containing compounds (e.g. Metastron®, Quadramet®)
* Platelet count \2x ULN
* Bilirubin (total) \>1.5x ULN; subjects with Gilbert's syndrome will be allowed if direct bilirubin is within institutional normal limits
* Active serious infection
* Active angina pectoris or NY Heart Association Class III-IV
* ECOG Performance Status \> 2
* Life expectancy \
Source: ClinicalTrials.gov (NCT00859781). StuddyBuddy aggregates publicly available trial information.