PSA biochemical failure after radical prostatectomy
Conditions
Interventions
Patients undergo leukapheresis for the harvest of peripheral blood mononuclear cells (PBMCs). PBMCs are stimulated with 2-methyl-3-butenyl-1-pyrophosphate and aldesleukin for 14 days. Patients then re
Sponsors
Tokyo Women's Medical University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Patients with histologically confirmed prostate carcinoma who had undergone radical prostatectomy 2) Patients with PSA biochemical failure and PSA<0.4ng/ml within 4 weeks before enrollment. 3) PSA doubling time is calculated and positive value before enrollment. 4) Patients who had no clinical recurrence and metastasis defined by CT and bone scintigraphy. 5) ECOG performance status 0-1 and age > 20-years old. 6) Leukocyte count &#8805; 3,000/mm&#179; ANC &#8805; 1,500/mm&#179; Platelet count &#8805; 100,000/mm&#179; Serum bilirubin &#8804; 1.5 mg/dL AST/ALT &#8804; 2.5 times normal Serum creatinine &#8804; 1.5 mg/dL LDH &#8804; 1.5 times normal Teststeron>150ng/dL 8) Patients who voluntarily provided written consent to participate in this trial after having been thoroughly briefed and informed of its nature were eligible for enrollment.
Exclusion criteria
Exclusion criteria: 1) No current treatment with any anti-cancer drugs and androgen depletion therapy. 2) No hypercalcemia that require medication, No C-reactive protein with an infectious disease that requires medication, No active infection with hepatitis virus or HIV, No current treatment with steroids, No poorly controlled DM or heart failure or arrhythmia, No autoimmune disease and interstitial pneumonia, No other malignancy, No bone of organ transplant recipient, Not pregnant nor nursing, No mental disorder. 3) Other patients judged to be ineligible by the attending investigators were also excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and efficacy: Adverts events are accessed by CTCAE ver.4.0. Efficacy is accessed by prolongation of PSA doubling time. | — |
Countries
Japan
Outcome results
None listed