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

NCT ID: NCT03129854

Last Updated: 2019-06-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-29
• Study Completion Date: 2026-06-30

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.

Conditions

Prostate Cancer Metastatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental group

Prostate cryotherapy plus ADT

Group Type: EXPERIMENTAL

prostate cryotherapy

Intervention Type: DEVICE

prostate cryotherapy added to experimental group within 6 months of ADT

control group

standard of care ADT continually

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

prostate cryotherapy

prostate cryotherapy added to experimental group within 6 months of ADT

Intervention Type: DEVICE

Other Intervention Names

prostate cryoablation

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yonghong Li

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Minghuang Hong, MD

Role: STUDY_DIRECTOR

Sun Yat-sen University

Locations

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yonghong Li, MD

Role: CONTACT

liyongh@sysucc.org.cn

86-20-87343656

Qiuhong Chen, MD

Role: CONTACT

chenqh@sysucc.org.cn

86-20-87343656

Facility Contacts

Yonghong Li, MD

Role: primary

liyongh@sysucc.org.cn

86-20-87343656

References

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.

Reference Type: BACKGROUND

PMID: 27174537 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24290503 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18817934 (View on PubMed)

Other Identifiers

YoLi

Identifier Type: -

Identifier Source: org_study_id