Clinical trial · Interventional
Prostate Conformal Cryotherapy
Regional Cryoablation for Localized Adenocarcinoma of the Prostate
NCT00877682CI-TRIAL-00031470completedN/AClinicalTrials.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)
The goal of this clinical research study is to learn if using cryotherapy to treat only the part of the prostate that contains cancer is an effective treatment for prostate cancer. The safety of this treatment will also be studied. Researchers also want to learn if treating only the part of the prostate with cancer causes less impact on your quality of life than other types of therapies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryoablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cryotherapy
- description
- Under general anesthetic using ultrasonic guidance, freezing (cryoablation) portion of prostate.
- interventionNames
- Procedure: Cryoablation
Primary outcomes (1)
- measure
- Patient Response
- timeFrame
- 6 months
- description
- Result of biopsy at 6 months after therapy. A failure event is either a Failure of Patient Selection or a Failure of Treatment.
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: 1. Histologically identified adenocarcinoma of the prostate by minimum 6 core prostate biopsy. 2. Serum PSA \</= 10 ng/mL before prostate biopsy 3. Less than 50% of samples from one side of the prostate positive for prostate cancer. 4. No greater than 50% of a single core total length occupied by prostate cancer. 5. No dominant Gleason 4 component. (e.g.; 4+X is not allowed, but X+4 is eligible) 6. No Gleason 5 component (primary, secondary or tertiary). 7. Subjects may have contralateral positive prostate biopsy in a single core within the eligibility biopsy so long as the involvement of this core is 2mm or less and no Gleason 4 or Gleason 5 pattern exists. This is considered to be Non-Dominant (Contralateral) Tumor Burden and is not exclusionary. 8. In the case that the confirmatory biopsy fails to sample the tumor again, patients will be allowed to continue into the therapeutic phase using the laterality information obtained during the eligibility biopsy. Exclusion Criteria: 1. Medical History or Concurrent Disease which in the investigators mind places the patient at significant preoperative risk or for which the investigator does not feel this therapy is appropriate. Investigator believes subject is unwilling or unable to comply with study protocol requirements. 2. AUASI (American Urologic Association Symptom Index) score \>/=20 3. Active urinary tract infection 4. Active treatment with anticoagulant/anti-platelet agent that cannot be safely stopped at the time of prostate biopsy and cryotherapy. 5. Medical or surgical castration initiated before or after the eligibility biopsy. 6. Patient is unable to provide informed consent. 7. Patients will undergo base line bone scan prior to cryoablation to evaluate for regions of abnormal uptake before therapeutic intervention. Metastatic disease by bone scintigraphy is exclusionary. Bone scans performed within 12 months prior to study entry will be used for study base line purposes and will not need to be repeated, unless clinically indicated.
References
Publications (0)
Data not yet available
No reference posted for this study.