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-05-1


FDG PET-CT in Metastatic Prostate Cancer.

Type: Screening/Diagnostic
Phase: Pilot
Status: Closed to Accrual with Ongoing Follow-up
Treatments: Other
Randomized: No
Defintions of terms and FAQ about clinical trials.
Trial Leaders/Researchers:  Hossein Jadvar, M.D.
Other Trial Staff:  Julia Quillen, R.N.

Staff may log in to see study documents.


You may participate in this study if:
 Requirement
1Male, 21 y/o and above
2Must have serum PSA more than or equal to 2 ng/mL (*see exception for Group II)
3Must have rising serum PSA level (defined as at least 2 consecutive rises in PSA documented over a reference value) ***1st measure (as reference value) : must be w/i 3 months prior to enrollment ***2nd measure (first rising PSA ): must be 14 days or more after the reference value ***3rd measure (confirmatory PSA) : must be 14 days or more after the 2nd measure & must be greater than the 2nd measure.
4Serum Creatinine must be less than or equal to 2.5 x ULN and must be w/i 28 days of enrollment
5Prior surgery allowed (must have completed surgery more 14 days prior to study treatment & must have recovered from any side effects)
6Men of childbearing potential must use effective contraception
7OPTIONAL: Completed baseline McGill Pain Questionnaire and analgesic pain survey
8Group I (hormone-naïve) inclusion criteria: •must have histological diagnosis of prostate adenocarcinoma, must be currently metastatic (TxNxM1) & is hormone-naïve •Must have conventional imaging evidence for metastatic disease by CT, bone scintigraphy or both.
9Group II (hormone-refractory) inclusion criteria: •must have histological diagnosis of prostate adenoca, must be currently metastatic (TxNxM1) & is unresponsive or refractory to hormonal treatment. •Progression of measurable disease assessed with CT or bone scan w/i 3 months •*No minimum PSA level is required if clinically symptomatic patients (e.g. metastasis-related bone pain) •Must have received prior hormonal therapy & must have castrate level of testosterone (pts treated with orchiectomy are eligible)
10Must sign Informed Consent (including HIPAA authorization)


You may not participate in this study if:
1History of other cancer except: squamous cell skin cancer treated with curative intent
2Active infection except mild Upper Respiratory Infections
3History of poorly-controlled Diabetes (FBG more than 200 mg/dL)
4Active inflammatory conditions (e.g. rheumatoid arthritis, sarcoid)
5History of complicated non-healing fracture



For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or clinical.trials@med.usc.edu.

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