NCT02615223

Brief Summary

This trial is going to evaluate tumor control and quality of life in patients with prostate cancer treated with endocrine therapy with or without cryoablation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

June 12, 2017

Status Verified

November 1, 2015

Enrollment Period

2.1 years

First QC Date

November 17, 2015

Last Update Submit

June 9, 2017

Conditions

Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (2)

  • Median biochemical progression-free survival

    It measures the time to biochemical progression (PSA progression).

    Within 12 months after treatment

  • Quality of Life impact of treatments' side effects measured by change in EORTC QOL-C30 from baseline to 3, 6 and 12 months after treatment

    European Organization for Research and Treatment of Cancer(EORTC)

    3, 6 and 12 months after treatment

Secondary Outcomes (2)

  • Overall survival

    5 year

  • Disease Specific Survival

    5 year

Study Arms (2)

Arm1

EXPERIMENTAL

Patients receive oral bicalutamide once daily on days 1-28. Patients also receive luteinizing-hormone releasing-hormone (LHRH) agonist treatment intramuscularly (IM) on day 8. Treatment with LHRH agonist repeats every 12 weeks for 24 weeks. Patients receive cryoablation therapy.

Procedure: cryoablationDrug: BicalutamideDrug: luteinizing-hormone releasing-hormone (LHRH) agonist

Arm2

EXPERIMENTAL

Patients receive oral bicalutamide once daily on days 1-28. Patients also receive luteinizing-hormone releasing-hormone (LHRH) agonist treatment intramuscularly (IM) on day 8. Treatment with LHRH agonist repeats every 12 weeks for 24 weeks.

Drug: BicalutamideDrug: luteinizing-hormone releasing-hormone (LHRH) agonist

Interventions

cryoablationPROCEDURE

Cryoablation therapy

Arm1
BicalutamideDRUG

bicalutamide

Arm1Arm2
luteinizing-hormone releasing-hormone (LHRH) agonistDRUG

luteinizing-hormone releasing-hormone (LHRH) agonist

Arm1Arm2

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prostate adenocarcinoma, T4N0M0, Any T with N+ or M+
  • Previously untreated disease or undergone endocrine therapy without reaching to castration resistant prostate cancer
  • Survival ≥ 12 months
  • WHO performance status 0-2
  • white blood cell ≥ 3.5 ×10\*9/L
  • Platelets ≥ 5×10\*9/L
  • Hemoglobin ≥ 10 g/dL

You may not qualify if:

  • History of malignant disease
  • History of coronary artery disease
  • Uncontrolled infection
  • Other concurrent severe or uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes mellitus, uncontrolled cardiac disease, uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within the past six months, chronic liver or renal disease, and active upper gastrointestinal tract ulceration)
  • Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study treatment and follow-up schedule

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

CryosurgerybicalutamideGonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, OperativePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Zhi Guo

    Tianjin Medical University Cancer Institue and Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi Guo, PhD

CONTACT

02223340123cjr.guozhi@vip.163.com

Xueling Yang

CONTACT

02223340123yxueling123@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2015

First Posted

November 26, 2015

Study Start

November 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

June 12, 2017

Record last verified: 2015-11

Locations

CN(1)