Study of Sipuleucel-T W/ or W/O Radium-223 in Men With Asymptomatic or Minimally Symptomatic Bone… (NCT02463799) | Clinical Trial Compass
CompletedPhase 2
Study of Sipuleucel-T W/ or W/O Radium-223 in Men With Asymptomatic or Minimally Symptomatic Bone-MCRPC
United States36 participantsStarted 2016-02-22
Plain-language summary
This clinical trial studies the effect of radium-223 when added to sipuleucel-T for treating castrate-resistant prostate cancer that has spread to the bone. Sipuleucel-T is an autologous cellular immunotherapy designed to stimulate an immune response against prostate cancer. It has been suggested that the immune response may be strengthened by radiation therapy. Therefore this study is testing whether radium-223 added to sipuleucel-T increases the immune response and anti-tumor effect against prostate cancer.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Written informed consent provided prior to initiation of study procedures
✓. Age ≥ 18 years
✓. Histologically documented adenocarcinoma prostate cancer confirmed by a pathology report from prostate biopsy or a radical prostatectomy specimen. If prostatic tumor is of mixed histology, \> 50% of the tumor must be adenocarcinoma
✓. Bone metastases as manifested by one or more lesions on a bone scan performed within 2 months of screening
✓. Castrate-resistant prostate cancer, in the setting of castrate levels of testosterone (≤ 50 ng/dL), defined as current or historical evidence of disease progression concomitant with surgical castration or androgen deprivation therapy (ADT), as demonstrated by two consecutive rises in PSA OR new lesions on bone scan:
✓. Serum PSA ≥ 2.0 ng/mL
✓. Screening ECOG perf status ≤ 1
✓. Asymptomatic or minimally symptomatic disease (no narcotic analgesic; other analgesics use is allowed)
Exclusion criteria
✕. The presence of known lung or liver metastases greater than 1.0 cm in the long axis diameter
✕. The presence of lymphadenopathy greater than 3 cm in the short-axis diameter
✕. The presence of known brain metastases
✕
What they're measuring
1
Immune Responses to Treatment With Sipuleucel-T (With or Without Radium-223) Measured by Peripheral PA2024 T-cell Proliferation
Timeframe: 6 weeks
Trial details
NCT IDNCT02463799
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
. Spinal cord compression, imminent long bone fracture, or any other condition that, in the opinion of the investigator, is likely to require radiation therapy and/or steroids for pain control during the active phase
✕. Previous treatment with chemotherapy for mCRPC (adjuvant chemotherapy is permitted), or chemotherapy for any reason within 2 years prior to registration
✕. Intention to receive chemotherapy within 6 months after enrollment in protocol therapy
✕. History of radiation therapy, either via external beam or brachytherapy within 28 days prior to registration
✕. Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks