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Cryotherapy

Arm I (cryotherapy, sargramostim) for Prostate Cancer

Phase 1
Waitlist Available
Led By Al Barqawi
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to up to 3 months after cryotherapy
Awards & highlights

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. Cryosurgery, also known as cryotherapy, kills tumor cells by freezing them. Giving sargramostim after cryotherapy may work better in treating prostate cancer.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to up to 3 months after cryotherapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to up to 3 months after cryotherapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in B cell response identified by Serametrix assay
Change in T cell responses identified by Intracellular cytokine assay and enzyme-linked immunospot

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (cryotherapy, sargramostim)Experimental Treatment2 Interventions
Patients undergo cryotherapy on day 0 and receive sargramostim subcutaneously on days 1, 3, 5, 8, 10, and 12.
Group II: Arm II (cryotherapy, standard of care)Active Control1 Intervention
Patients undergo cryotherapy on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cryotherapy
2016
Completed Phase 4
~9520
sargramostim
1996
Completed Phase 3
~4880

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,786 Previous Clinical Trials
2,787,589 Total Patients Enrolled
14 Trials studying Prostate Cancer
3,028 Patients Enrolled for Prostate Cancer
EDAP TMS S.A.Industry Sponsor
8 Previous Clinical Trials
711 Total Patients Enrolled
2 Trials studying Prostate Cancer
341 Patients Enrolled for Prostate Cancer
Al BarqawiPrincipal InvestigatorUniversity of Colorado, Denver
~2 spots leftby Sep 2025
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