Androgen Deprivation Therapy (ADT) Versus ADT Plus Prostate Cryotherapy for Metastatic Prostate Cancer (mPCa)

June 5, 2019 updated by: Yonghong Li, Sun Yat-sen University

A Randomized Study of Androgen Deprivation Therapy Versus Androgen Deprivation Therapy Plus Prostate Cryotherapy in the Treatment of Patients With Primary Diagnosed Metastatic Prostate Cancer

Patients with primary diagnosed metastatic prostate cancer are randomly divided into two groups. One group receive standard of care ADT continually. Another group receive ADT plus prostate cryotherapy. Patients are followed up until their death or withdraw from this study due to other reasons. The primary endpoint of this study is prostate cancer Progression-Free Survival. The secondary endpoint is overall survival, prostate cancer specific survival and health-related quality of life.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Ages Eligible for Study: 18 Years and older.

Genders Eligible for Study: Male.

Accepts Healthy Volunteers: No.

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-Sen University Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Have histologically diagnosed prostate cancer
  • Metastatic disease diagnosed by CT scan, MRI scan or bone scan. M stage M1a or M1b according to 2010 American joint Committee on Cancer (AJCC) stage system
  • Be willing and able to provide written informed consent/assent for the trial
  • Eastern Cooperative Oncology Group (ECOG) performance scale status of 0 or 1
  • Calculator of overall mortality risk at 3 years less than 70%( Eur Urol. 2016 May 9. pii: S0302-2838(16)30141-5. )
  • Time interval between hormonal therapy and randomization less than 6 months
  • Can tolerate general anesthesia and cryosurgery
  • Demonstrate adequate organ function

Exclusion Criteria:

  • According to the doctor's judgment, the patients had any serious illness or other clinical conditions, can't safely undergo the clinical research, any other serious diseases or clinical situation is not limited to the items listed below:

    • Infection ≥ grade 2 according to National Cancer Institute on the common terminology criteria for adverse events (NCI-CTCAE) version 4.03,
    • Heart failure (New York heart group NYHA) III or IV,
    • Crohn's disease or ulcerative colitis,
    • Fecal incontinence,
    • Substance abuse, medical, psychological or social problems that may interfere with the evaluation of the results of this study,
    • The presence of any unstable disease or clinical condition, potential harm to the safety of the subject or influence the subject's compliance.
  • Other malignancies (within 5 years), except for non melanoma skin cancer. Patients with other malignancies who survived with effective treatment and randomized to have no evidence of cancer for more than 5 years were allowed to participate in the study
  • Treatment of prostate cancer other than hormonal therapy (except bisphosphonate therapy for bone metastases)
  • After 6 months of hormonal treatment, the prostate volume greater than 55ml

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
Prostate cryotherapy plus ADT
Device: prostate cryotherapy
prostate cryotherapy added to experimental group within 6 months of ADT
Other Names:
  • prostate cryoablation
No Intervention: control group
standard of care ADT continually

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prostate Cancer Progression-Free Survival
Time Frame: through study completion, an average of 48 months
Prostate Cancer Progression-Free Survival (PFS), from beginning of ADT to progression of prostate cancer
through study completion, an average of 48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: through study completion, an average of 60 months
Overall Survival (OS), from beginning of ADT to death
through study completion, an average of 60 months
prostate cancer specific survival
Time Frame: through study completion, an average of 60 months
prostate cancer specific survival (CSS), from beginning of ADT to death from prostate cancer
through study completion, an average of 60 months
Functional Assessment of Cancer Therapy-Prostate
Time Frame: through study completion, an average of 48 months
Functional Assessment of Cancer Therapy-Prostate (FACT-P), From beginning of ADT to death
through study completion, an average of 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Study Director: Minghuang Hong, MD, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2017

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

June 30, 2026

Study Registration Dates

First Submitted

April 16, 2017

First Submitted That Met QC Criteria

April 25, 2017

First Posted (Actual)

April 26, 2017

Study Record Updates

Last Update Posted (Actual)

June 7, 2019

Last Update Submitted That Met QC Criteria

June 5, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YoLi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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