Suspended

CRYO-PCA-IIIA Prospective Multi-center Study to Compare the QOL and Efficacy of External Beam Radiation Therapy or Cryoablation Therapy for Stage III Prostate Cancer

What is being tested

Cryoablation therapy

+ bicalutamide

+ luteinizing-hormone releasing-hormone (LHRH) agonist

ProcedureDrugRadiation

Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

From 18 to 80 Years

+12 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: November 2015

See protocol details

Summary

Principal SponsorTianjin Medical University Cancer Institute and Hospital

Study ContactZhi Guo, PhDMore contacts

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2015

Actual date on which the first participant was enrolled.

OBJECTIVES: * To determine the tumor control in patients with prostate cancer treated with radiotherapy or cryoablation * To determine the quality of life of these patients. OUTLINE: This is a multicenter study. Patients are stratified according to Gleason score (≥ 8 vs 7 vs ≤ 6), persistent prostatic specific antigen (PSA) at allocation (> 0.5 ng/mL vs ≤ 0.5 ng/mL), participating center. Patient are allocated to two treatment arms.

Official TitleA Prospective Multi-center Study to Compare the QOL and Efficacy of External Beam Radiation Therapy or Cryoablation Therapy for Stage III Prostate Cancer

NCT02605226

Principal SponsorTianjin Medical University Cancer Institute and Hospital

Study ContactZhi Guo, PhDMore contacts

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

240 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesProstatic NeoplasmsUrogenital NeoplasmsMale Urogenital Diseases

Criteria

7 inclusion criteria required to participate

Prostate adenocarcinoma, T3aN0M0, T3bN0M0

Previously untreated disease or undergone endocrine therapy without reaching to castration resistant prostate cancer

Survival ≥ 12 months

WHO performance status 0-2

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5 exclusion criteria prevent from participating

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)

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

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.

Group II

Experimental

Patients receive androgen ablation as in arm I. Patients receive external beam radiation therapy.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Tianjin Medical University Cancer Hospital

Tianjin, ChinaOpen Tianjin Medical University Cancer Hospital in Google Maps

SuspendedOne Study Center