Prostate CancerNCT00877682
Prostate Conformal Cryotherapy
A study testing Cryoablation in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Cryoablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2009to 14 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Regional Cryoablation for Localized Adenocarcinoma of the Prostate
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.
Read the detailed description
Cryotherapy (also called cryoablation) is an FDA approved treatment for prostate cancer. It involves placing multiple needles within the prostate and freezing the prostate, which will destroy both the cancerous and normal prostate tissue in a very controlled manner. It is possible to treat less than the whole prostate by only freezing the area of the prostate known to contain the cancer.
For this study, cryotherapy will be performed in a way similar to whole prostate cryotherapy, except the entire prostate will not be frozen. For this study, only that portion of the prostate with the most prostate cancer and the upper half of the opposite side of location of the cancer in the prostate will be treated. All areas of cancer may not be treated.
Cryotherapy:
Cryotherapy is performed under general anesthetic in the operating room. An ultrasound probe is inserted into the rectum to monitor the tissue freezing. A urethral warmer is inserted into the bladder through the penis to maintain the health of the urethra.
Quality-of-Life Questionnaires:
You will complete quality-of-life questionnaires before the prostate biopsy, and then at 3, 6, 12, 18, 24, 30, and 36 months after cryotherapy. The questionnaires will ask about your general health and your urinary, bowel, and sexual functions. The questionnaire should take about 15 minutes to complete each time.
Digital Rectal Exams and PCA3 Testing:
Before your cryotherapy and again before the biopsies at Months 6, 18 and 36 you will have a digital rectal exam (feeling the prostate through your anus) to check the status of the disease. You will also have digital rectal exams at Months 48 and 60 to check the status of the disease.
Urine will be collected after each digital rectal exam. This sample will be tested for PCA3, which has been associated with prostate cancer.
Prostate Biopsies:
You will have additional prostate biopsies at 6, 18, and 36 months after cryotherapy. About 12 biopsies samples will be collected each time from the same locations as during the screening biopsy. If you have rising PSA levels or your doctor thinks it is necessary, you and your doctor will discuss the need additional biopsies at Months 48 and 60.
This is an investigational study. Cryotherapy is FDA approved for the destruction of tissue, including prostate tissue. For the treatment of prostate cancer, it is commonly used to treat the entire prostate gland. This study is investigational because only a part of the prostate gland will be treated, instead of the entire gland. Partial organ treatment with cryotherapy is common for treatment of kidney, liver, and skin lesions.
Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Prostate Cancer
- Being tested
- Cryoablation
- Keywords
- Prostate Cancer, Prostate Tumor, Adenocarcinoma of the Prostate, PCA, Regional Prostate Cryoablation, Cryotherapy, Cryoablation, Health Related Quality of Life, HRQOL
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoablationProcedure or surgery
Also called Cryotherapy
Under general anesthetic using ultrasonic guidance, freezing (cryoablation) portion of prostate.
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy | Experimental | Under general anesthetic using ultrasonic guidance, freezing (cryoablation) portion of prostate. Receives: Procedure: Cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Response
Result of biopsy at 6 months after therapy. A failure event is either a Failure of Patient Selection or a Failure of Treatment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study start6 Apr 2009
- Primary completion14 Jan 2018
- Study completion14 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Endocare, Inc., Gen-Probe, Incorporated, FirmaMed, Envisioneering Medical Technologies
- Responsible party
- Sponsor
- Investigators
- John F. Ward, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877682
- Sponsor's protocol ID
- 2008-0244
- Other IDs
- NCI-2011-01340
- Status last verified
- Jan 2018
- First submitted
- 7 Apr 2009
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Cryoablation for Localized Adenocarcinoma of the Prostate
- ClinicalTrials.gov ID
- NCT00877682
- Acronym / sponsor ID
- 2008-0244
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Prostate Tumor, Adenocarcinoma of the Prostate, PCA, Regional Prostate Cryoablation, Cryotherapy, Cryoablation, Health Related Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Endocare, Inc., Gen-Probe, Incorporated, FirmaMed, Envisioneering Medical Technologies
- Study start
- 6 Apr 2009 (actual)
- Primary completion
- 14 Jan 2018 (actual)
- Study completion
- 14 Jan 2018 (actual)
- First posted
- 8 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cryotherapy (also called cryoablation) is an FDA approved treatment for prostate cancer. It involves placing multiple needles within the prostate and freezing the prostate, which will destroy both the cancerous and normal prostate tissue in a very controlled manner. It is possible to treat less than the whole prostate by only freezing the area of the prostate known to contain the cancer.
For this study, cryotherapy will be performed in a way similar to whole prostate cryotherapy, except the entire prostate will not be frozen. For this study, only that portion of the prostate with the most prostate cancer and the upper half of the opposite side of location of the cancer in the prostate will be treated. All areas of cancer may not be treated.
Cryotherapy:
Cryotherapy is performed under general anesthetic in the operating room. An ultrasound probe is inserted into the rectum to monitor the tissue freezing. A urethral warmer is inserted into the bladder through the penis to maintain the health of the urethra.
Quality-of-Life Questionnaires:
You will complete quality-of-life questionnaires before the prostate biopsy, and then at 3, 6, 12, 18, 24, 30, and 36 months after cryotherapy. The questionnaires will ask about your general health and your urinary, bowel, and sexual functions. The questionnaire should take about 15 minutes to complete each time.
Digital Rectal Exams and PCA3 Testing:
Before your cryotherapy and again before the biopsies at Months 6, 18 and 36 you will have a digital rectal exam (feeling the prostate through your anus) to check the status of the disease. You will also have digital rectal exams at Months 48 and 60 to check the status of the disease.
Urine will be collected after each digital rectal exam. This sample will be tested for PCA3, which has been associated with prostate cancer.
Prostate Biopsies:
You will have additional prostate biopsies at 6, 18, and 36 months after cryotherapy. About 12 biopsies samples will be collected each time from the same locations as during the screening biopsy. If you have rising PSA levels or your doctor thinks it is necessary, you and your doctor will discuss the need additional biopsies at Months 48 and 60.
This is an investigational study. Cryotherapy is FDA approved for the destruction of tissue, including prostate tissue. For the treatment of prostate cancer, it is commonly used to treat the entire prostate gland. This study is investigational because only a part of the prostate gland will be treated, instead of the entire gland. Partial organ treatment with cryotherapy is common for treatment of kidney, liver, and skin lesions.
Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy | Experimental | Procedure: CryoablationUnder general anesthetic using ultrasonic guidance, freezing (cryoablation) portion of prostate. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryoablationAlso: CryotherapyUnder general anesthetic using ultrasonic guidance, freezing (cryoablation) portion of prostate. | Procedure or surgery | Cryotherapy |
Primary outcome
Patient Response
Time frame: 6 months
Result of biopsy at 6 months after therapy. A failure event is either a Failure of Patient Selection or a Failure of Treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John F. Ward, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Response (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2018; AzTrials last refreshed its copy on 27 Oct 2026.