Clinical trial · Interventional
The Immuno-Response to Primary Cryotherapy for the Treatment of Prostate Cancer
NCT02250014CI-TRIAL-00056419completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized pilot phase I trial studies how well sargramostim after cryotherapy works in treating patients with prostate cancer. Biological therapies, such as sargramostim, use substances made from living organisms that may stimulate the immune system in different ways and stop tumor cells from growing. Cryosurgery, also known as cryotherapy, kills tumor cells by freezing them. Giving sargramostim after cryotherapy may work better in treating prostate cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cryotherapy | Procedure | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (cryotherapy, sargramostim)
- description
- Patients undergo cryotherapy on day 0 and receive sargramostim subcutaneously on days 1, 3, 5, 8, 10, and 12.
- interventionNames
- Procedure: cryotherapy
- Biological: sargramostim
- type
- ACTIVE_COMPARATOR
- label
- Arm II (cryotherapy, standard of care)
- description
- Patients undergo cryotherapy on day 0.
- interventionNames
- Procedure: cryotherapy
Primary outcomes (2)
- measure
- Change in B cell response identified by Serametrix assay
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with prostate cancer that elect to undergo primary cryotherapy of the prostate * Patients who are diagnosed with clinical stage T1a -T2c prostate cancer * Gleason score sum of less than or equal to 7 * Prostate-specific antigen (PSA) \< 20 ng/dl * Patient will read, understand and sign the informed consent and Health Insurance Portability and Accountability Act (HIPAA) agreement * Patients must have a life expectancy of at least one year Exclusion Criteria: * Known hypersensitivity to granulocyte macrophage colony stimulating factor (GM-CSF) or yeast * Anticipated blood donation within the next 90 days * Magnetic resonance imaging (MRI), computed tomography (CT) and bone scan evidence of metastatic prostate cancer regardless the PSA level; (the indication for which is clinically driven and at the discretion of the treating physician) * Any history of current or within the past 48 hours of acute or chronic bacterial, fungal or viral infectious disease * Documented excessive leukemic myeloid blasts in the bone marrow or peripheral blood (\>= 10%) in the past 6 months * Previous organ transplant * Immunosuppression including primary, secondary, iatrogenic and idiopathic * Other serious diseases (hematological, hepatic, renal, respiratory, central nervous system, autoimmune or psychiatric) * Enrollment in other studies for any disease in the past 30 days * Diagnosis of cancer that in not considered cured, except basal cell carcinoma (BCC) of skin * Prior transurethral resection of the prostate with a large tissue defect (at the discretion of the investigator) * History of abdominoperineal resection for rectal cancer, rectal stenosis, or other major rectal pathology * Patient currently receiving lithium, steroid, chemotherapy or radiotherapy treatment * Patients with a Hemoglobin of less than 12%
References
Publications (0)
Data not yet available
No reference posted for this study.