University of Southern California
USC Norris Comprehensive Cancer Center
If you are a patient, please contact Keck Medical Center of USC at 800-USC-CARE.

Trial 4P-09-5

A Randomized Phase II Trial of 177Lu Radiolabeled Monochlonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients with High-Risk Castrate Biochemically Relapsed Prostate Cancer After Local Therapy.

Type: Treatment
Phase: Phase II
Status: Closed to Accrual with Ongoing Follow-up
Treatments: Immunomodulator
Randomized: Yes
Defintions of terms and FAQ about clinical trials.
Trial Leaders/Researchers:  David Quinn, M.D.
Other Trial Staff:  Charlean Ketchens, R.N., Lagrimas Ilagan, D.M., Kristy Sartor Massopust, Coordinator, Honorina Enright, D.M., Torsten Fischer, R.N.

Staff may log in to see study documents.

You may participate in this study if:
1Histologically or cytologically confirmed adenocarcinoma of the prostate previously treated with surgery and/or RT
2Biochemical progression (rising PSA) after medical or surgical castration
3High risk of systemic progression
4No evidence of local recurrence or distant metastases within 1 month of enrollment (or following enrollment as part of screening) including: [1] Radionuclide bone scan without evidence of metastatic disease; [2] CT or MRI of abdomen/pelvis without evidence of metastatic disease or recurrent disease in the prostate or prostate bed; [3] CXR or CT of chest without evidence of metastatic disease
5At least 18 years of age
6ECOG performance status < / = 2
7Life expectancy at least 12 months
8AGC = / > 2.0; platelets = / > 150,000; Hgb = / > 10 or Hct = / > 30%
9SGOT < / = 2 x uln; total bilirubin < / = 1.5 x uln (subjects with Gilbert’s syndrome will be allowed if direct bilirubin is wnl)
10Creatinine < / = 2.5
11Serum calcium < / = 11
12PT or INR, PTT < / = 1.3 x uln (unless on therapeutic anti-coagulation)
13Serum testosterone <50 ng/ml
14Patients capable of fathering children must agree to use an effective method of contraception for the duration of the trial
15Subjects on bisphosphonate therapy must be on a stable dose and must have started therapy >4 weeks prior to protocol therapy. Initiation of bisphosphonate therapy is not allowed during the treatment phase.
16Signed an approved study-specific informed consent and HIPAA

You may not participate in this study if:
1Use of red blood cell or platelet transfusions within 4 weeks of treatment
2Use of hematopoietic growth factors within 4 weeks of treatment
3Prior cytotoxic chemotherapy and/or RT within 4 weeks of treatment
4Prior RT encompassing >25% of skeleton
5Prior treatment with 89Strontium or 153Samarium containing compounds (e.g., Metastron, Quadramet)
6Active serious infection
7Active angina pectoris or NYHA Class III-IV
8History of DVT and/or PE within 1 month of study entry
9Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.
10Prior investigational therapy (medications or devices) within 4 weeks of treatment. Furthermore, other investigational therapy is not permitted during the treatment phase.
11Prior use of ketoconazole for the purposes of prostate cancer therapy
12Known history of HIV
13Currently active other malignancy other than non-melanoma skin cancer
14Adrenal hormone inhibitors (other than ketoconazole) within 4 weeks prior to study enrollment
15Finasteride ((Propecia or Proscar) or dutasteride (Avodart) within 4 weeks of enrollment
16Finasteride ((Propecia or Proscar) or dutasteride (Avodart) within 4 weeks of enrollment

For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or

To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.