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

Primary Purpose

Prostate Cancer Metastatic

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
prostate cryotherapy
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer Metastatic focused on measuring prostate cancer, metastatic, cryotherapy, ADT

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sun Yat-Sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental group

control group

Arm Description

Prostate cryotherapy plus ADT

standard of care ADT continually

Outcomes

Primary Outcome Measures

Prostate Cancer Progression-Free Survival
Prostate Cancer Progression-Free Survival (PFS), from beginning of ADT to progression of prostate cancer

Secondary Outcome Measures

Overall Survival
Overall Survival (OS), from beginning of ADT to death
prostate cancer specific survival
prostate cancer specific survival (CSS), from beginning of ADT to death from prostate cancer
Functional Assessment of Cancer Therapy-Prostate
Functional Assessment of Cancer Therapy-Prostate (FACT-P), From beginning of ADT to death

Full Information

First Posted
April 16, 2017
Last Updated
June 5, 2019
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03129854
Brief Title
Androgen Deprivation Therapy (ADT) Versus ADT Plus Prostate Cryotherapy for Metastatic Prostate Cancer (mPCa)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2017 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Ages Eligible for Study: 18 Years and older. Genders Eligible for Study: Male. Accepts Healthy Volunteers: No.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer Metastatic
Keywords
prostate cancer, metastatic, cryotherapy, ADT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One group receive standard of care ADT continually. Another group receive ADT plus prostate cryotherapy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
Prostate cryotherapy plus ADT
Arm Title
control group
Arm Type
No Intervention
Arm Description
standard of care ADT continually
Intervention Type
Device
Intervention Name(s)
prostate cryotherapy
Other Intervention Name(s)
prostate cryoablation
Intervention Description
prostate cryotherapy added to experimental group within 6 months of ADT
Primary Outcome Measure Information:
Title
Prostate Cancer Progression-Free Survival
Description
Prostate Cancer Progression-Free Survival (PFS), from beginning of ADT to progression of prostate cancer
Time Frame
through study completion, an average of 48 months
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall Survival (OS), from beginning of ADT to death
Time Frame
through study completion, an average of 60 months
Title
prostate cancer specific survival
Description
prostate cancer specific survival (CSS), from beginning of ADT to death from prostate cancer
Time Frame
through study completion, an average of 60 months
Title
Functional Assessment of Cancer Therapy-Prostate
Description
Functional Assessment of Cancer Therapy-Prostate (FACT-P), From beginning of ADT to death
Time Frame
through study completion, an average of 48 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Gender identity
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yonghong Li, MD
Phone
86-20-87343656
Email
liyongh@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Qiuhong Chen, MD
Phone
86-20-87343656
Email
chenqh@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minghuang Hong, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
Sun Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yonghong Li, MD
Phone
86-20-87343656
Email
liyongh@sysucc.org.cn

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27174537
Citation
Loppenberg B, Dalela D, Karabon P, Sood A, Sammon JD, Meyer CP, Sun M, Noldus J, Peabody JO, Trinh QD, Menon M, Abdollah F. The Impact of Local Treatment on Overall Survival in Patients with Metastatic Prostate Cancer on Diagnosis: A National Cancer Data Base Analysis. Eur Urol. 2017 Jul;72(1):14-19. doi: 10.1016/j.eururo.2016.04.031. Epub 2016 May 9.
Results Reference
background
PubMed Identifier
24290503
Citation
Culp SH, Schellhammer PF, Williams MB. Might men diagnosed with metastatic prostate cancer benefit from definitive treatment of the primary tumor? A SEER-based study. Eur Urol. 2014 Jun;65(6):1058-66. doi: 10.1016/j.eururo.2013.11.012. Epub 2013 Nov 20.
Results Reference
background
PubMed Identifier
18817934
Citation
Babaian RJ, Donnelly B, Bahn D, Baust JG, Dineen M, Ellis D, Katz A, Pisters L, Rukstalis D, Shinohara K, Thrasher JB. Best practice statement on cryosurgery for the treatment of localized prostate cancer. J Urol. 2008 Nov;180(5):1993-2004. doi: 10.1016/j.juro.2008.07.108. Epub 2008 Sep 25. No abstract available.
Results Reference
background

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

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