Prostate Conformal Cryotherapy

Completed · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00877682

Run by

M.D. Anderson Cancer Center

People needed

48

Starts

2009-04-06

Expected to finish

2018-01-14

Last updated by the study team

2018-01-31

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologically identified adenocarcinoma of the prostate by minimum 6 core prostate biopsy.
• Serum PSA </= 10 ng/mL before prostate biopsy
• Less than 50% of samples from one side of the prostate positive for prostate cancer.
• No greater than 50% of a single core total length occupied by prostate cancer.
• No dominant Gleason 4 component. (e.g.; 4+X is not allowed, but X+4 is eligible)
• No Gleason 5 component (primary, secondary or tertiary).
• 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.
• 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.

You may not qualify if…

• 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.
• AUASI (American Urologic Association Symptom Index) score >/=20
• Active urinary tract infection
• Active treatment with anticoagulant/anti-platelet agent that cannot be safely stopped at the time of prostate biopsy and cryotherapy.
• Medical or surgical castration initiated before or after the eligibility biopsy.
• Patient is unable to provide informed consent.
• 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.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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