Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Outcomes of Focal Therapies for Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03492424
Recruitment Status : Recruiting
First Posted : April 10, 2018
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
The purpose of this study is collect observational data regarding patterns of care and outcomes of focal therapies for prostate cancer, including but not limited to: high-intensity focused ultrasound (HIFU), cryotherapy, focal laser ablation, irreversible electroporation, photodynamic therapy, and brachytherapy.

Condition or disease Intervention/treatment
Prostate Cancer Device: cryotherapy

Detailed Description:
Through the use of a prospective registry, the investigators will collect information on patient characteristics including age, co-morbidities, imaging and biopsy information, and prior treatments. Information on treatment details will also be captured, including treatment time, anesthesia delivered, and length of stay, when applicable. Oncologic outcomes including PSA, post-treatment biopsy and imaging data, need for re-treatment, and survival outcomes will also be captured. Safety outcomes will be captured using the Clavien-Dindo classification scale, and additional specific GU complications will be recorded, which include urinary retention, urethral stricture, recto-urethral fistula, osteomyelitis, and urinary tract infection. Finally, the investigators will capture functional outcomes using health related quality of life questionnaires including the EPIC questionnaire, IIEF-5, MSHQ-EjD, and IPSS.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Outcomes of Focal Therapies for Prostate Cancer
Actual Study Start Date : January 2, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
Focal therapy for prostate cancer

All men >18 years of age undergoing focal therapy for primary or salvage treatment of prostate cancer will be included. Men who had received prior focal therapy are also eligible for inclusion.

The purpose of this study is collect observational data regarding patterns of care and outcomes of focal therapies for prostate cancer, including but not limited to: high-intensity focused ultrasound (HIFU), cryotherapy, focal laser ablation, irreversible electroporation, photodynamic therapy, and brachytherapy.

Device: cryotherapy
Subjects will receive focal cryotherapy for treatment of prostate cancer




Primary Outcome Measures :
  1. Prostate biopsy Gleason grade [ Time Frame: 12 months ]
    Will be obtained through patient biopsy pathology results


Secondary Outcome Measures :
  1. Patient characteristics/demographics [ Time Frame: 12 months ]
    Will be obtained through patient medical history in electronic health record

  2. MRI PI-RAD grade [ Time Frame: 12 months ]
    Will be obtained through patient MRI radiology results

  3. Lab results - PSA level [ Time Frame: 12 months ]
    Will obtain patient PSA (ng/mL) through laboratory (blood) results

  4. Patient-reported quality of life: EPIC-26 [ Time Frame: 12 months ]
    Expanded Prostate Cancer Index Composite (short form) questionnaire to assess quality of life

  5. Patient-reported quality of life: IIEF-5 [ Time Frame: 12 months ]
    The International Index of Erectile Function questionnaire to assess erectile function

  6. Patient-reported quality of life: MSHQ-EjD [ Time Frame: 12 months ]
    Male Sexual Health questionnaire to assess ejaculatory function

  7. Patient-reported quality of life: IPSS [ Time Frame: 12 months ]
    International Prostate Symptom Score questionnaire to assess urinary function and quality of life



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants are generally healthy men diagnosed with prostate cancer, undergoing focal therapy for treatment of prostate cancer.
Criteria

Inclusion Criteria:

  • >18 years of age
  • Undergoing focal therapy for primary or salvage treatment of prostate cancer, or
  • Have received prior focal therapy

Exclusion Criteria:

  • Clinically-evident metastatic disease
  • Unable to fill out an English-language questionnaire

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03492424


Contacts
Layout table for location contacts
Contact: Miko Yu 212-746-1496 mey2006@med.cornell.edu

Locations
Layout table for location information
United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Miko Yu    212-746-1496    mey2006@med.cornell.edu   
Principal Investigator: Jim C Hu, M.D., M.P.H.         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Layout table for investigator information
Principal Investigator: Jim C Hu, M.D., M.P.H. Weill Cornell Medicine

Additional Information:

Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03492424     History of Changes
Other Study ID Numbers: 1702018011
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Weill Medical College of Cornell University:
prostate cancer
cryotherapy
focal therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases