Recurrent Prostate CancerPhase 1NCT02250014
The Immuno-Response to Primary Cryotherapy for the Treatment of Prostate Cancer
A Phase 1 study testing cryotherapy and sargramostim in people with Recurrent Prostate Cancer and Stage I Prostate Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer
- What is being tested?
- cryotherapy and sargramostim
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2015to 21 Dec 2020
- Phase
- Phase 1
- 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 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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%
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Cancer Center
Aurora, Colorado, 80045
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine an unknown normal immune response (T cell and B cell) to post-cryotherapy treatment for prostate cancer.
II. Detect the altered immune response (T cell and B cell) post-GM-CSF (sargramostim) response and post-cryotherapy for the prostate cancer.
Patients are randomized to 1 of 2 treatment arms.
ARM I (TREATMENT): Patients undergo cryotherapy on day 0 and receive sargramostim subcutaneously (SC) on days 1, 3, 5, 8, 10, and 12.
ARM II (CONTROL): Patients undergo cryotherapy on day 0.
After completion of study treatment, patients are followed up for 6 months.
- Conditions
- Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
- Being tested
- cryotherapy, sargramostim
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryotherapyProcedure or surgery
Undergo cryotherapy
sargramostimBiological
Also called GM-CSF, Leukine, Prokine
Given subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Arm I (cryotherapy, sargramostim) | Experimental | Patients undergo cryotherapy on day 0 and receive sargramostim subcutaneously on days 1, 3, 5, 8, 10, and 12. Receives: Procedure: cryotherapy; Biological: sargramostim |
| Arm II (cryotherapy, standard of care) | Active comparator | Patients undergo cryotherapy on day 0. Receives: Procedure: cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in B cell response identified by Serametrix assay
A scatter plot of each cytokine and antigen level will be created for each patient by marker to observe the behavior of the markers (rising, falling, flat, or combination over time). Patient specific pre-operative levels will be used to obtain individual baseline measures from which the difference in follow-up cytokine and antigen levels will be calculated, then a simple descriptive comparison of the mean elevation in the markers' levels across cohorts will be graphed.
Measured: Baseline to up to 3 months after cryotherapy
Change in T cell responses identified by Intracellular cytokine assay and enzyme-linked immunospot
A scatter plot of each cytokine and antigen level will be created for each patient by marker to observe the behavior of the markers (rising, falling, flat, or combination over time). Patient specific pre-operative levels will be used to obtain individual baseline measures from which the difference in follow-up cytokine and antigen levels will be calculated, then a simple descriptive comparison of the mean elevation in the markers' levels across cohorts will be graphed.
Measured: Baseline to up to 3 months after cryotherapy
Secondary outcomes (1)
Change in PSA levels in serum samples
Measured: Up to 6 months after cryotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study start5 Oct 2015
- Primary completion1 Dec 2017
- Study completion21 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- EDAP TMS S.A.
- Responsible party
- Sponsor
- Investigators
- Al Barqawi, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250014
- Sponsor's protocol ID
- 14-0071.cc
- Other IDs
- 14-0071
- Status last verified
- Feb 2022
- First submitted
- 23 Sep 2014
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immuno-Response to Primary Cryotherapy for the Treatment of Prostate Cancer
- ClinicalTrials.gov ID
- NCT02250014
- Acronym / sponsor ID
- 14-0071.cc
- Conditions
- Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- EDAP TMS S.A.
- Study start
- 5 Oct 2015 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 26 Sep 2014 (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.
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.
Detailed description
PRIMARY OBJECTIVES:
- Determine an unknown normal immune response (T cell and B cell) to post-cryotherapy treatment for prostate cancer.
II. Detect the altered immune response (T cell and B cell) post-GM-CSF (sargramostim) response and post-cryotherapy for the prostate cancer.
Patients are randomized to 1 of 2 treatment arms.
ARM I (TREATMENT): Patients undergo cryotherapy on day 0 and receive sargramostim subcutaneously (SC) on days 1, 3, 5, 8, 10, and 12.
ARM II (CONTROL): Patients undergo cryotherapy on day 0.
After completion of study treatment, patients are followed up for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (cryotherapy, sargramostim) | Experimental | Procedure: cryotherapy, Biological: sargramostimPatients undergo cryotherapy on day 0 and receive sargramostim subcutaneously on days 1, 3, 5, 8, 10, and 12. |
| Arm II (cryotherapy, standard of care) | Active comparator | Procedure: cryotherapyPatients undergo cryotherapy on day 0. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| cryotherapyUndergo cryotherapy | Procedure or surgery | Arm I (cryotherapy, sargramostim), Arm II (cryotherapy, standard of care) |
| sargramostimAlso: GM-CSF, Leukine, ProkineGiven subcutaneously | Biological | Arm I (cryotherapy, sargramostim) |
Primary outcome
Change in B cell response identified by Serametrix assay
Time frame: Baseline to up to 3 months after cryotherapy
A scatter plot of each cytokine and antigen level will be created for each patient by marker to observe the behavior of the markers (rising, falling, flat, or combination over time). Patient specific pre-operative levels will be used to obtain individual baseline measures from which the difference in follow-up cytokine and antigen levels will be calculated, then a simple descriptive comparison of the mean elevation in the markers' levels across cohorts will be graphed.
Change in T cell responses identified by Intracellular cytokine assay and enzyme-linked immunospot
Time frame: Baseline to up to 3 months after cryotherapy
A scatter plot of each cytokine and antigen level will be created for each patient by marker to observe the behavior of the markers (rising, falling, flat, or combination over time). Patient specific pre-operative levels will be used to obtain individual baseline measures from which the difference in follow-up cytokine and antigen levels will be calculated, then a simple descriptive comparison of the mean elevation in the markers' levels across cohorts will be graphed.
1 secondary outcome
Change in PSA levels in serum samples
Time frame: Up to 6 months after cryotherapy
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 9 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Al Barqawi principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cryotherapy and sargramostim in people with Recurrent Prostate Cancer and Stage I Prostate Cancer, run by University of Colorado, Denver 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 6 inclusion and 14 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 9 Feb 2022. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in B cell response identified by Serametrix assay (time frame: Baseline to up to 3 months after cryotherapy). The study lists 2 primary outcomes in all. 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 9 Feb 2022.