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

Prostate Cancer Metastatic Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03129854
• Other study ID #: YoLi
• Status: Recruiting
• Phase: N/A
• Start date: March 29, 2017
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2019
• Source: Sun Yat-sen University
• Contact: Yonghong Li, MD
• Phone: 86-20-87343656
• Email: liyongh[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Ages Eligible for Study: 18 Years and older.

Genders Eligible for Study: Male.

Accepts Healthy Volunteers: No.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 30, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer Metastatic
• Prostatic Neoplasms

Intervention

Device:
• prostate cryotherapy
prostate cryotherapy added to experimental group within 6 months of ADT

Locations

Country	Name	City	State
China	Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (3)

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. Review. — View 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. — View Citation

Löppenberg 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate Cancer Progression-Free Survival	Prostate Cancer Progression-Free Survival (PFS), from beginning of ADT to progression of prostate cancer	through study completion, an average of 48 months
Secondary	Overall Survival	Overall Survival (OS), from beginning of ADT to death	through study completion, an average of 60 months
Secondary	prostate cancer specific survival	prostate cancer specific survival (CSS), from beginning of ADT to death from prostate cancer	through study completion, an average of 60 months
Secondary	Functional Assessment of Cancer Therapy-Prostate	Functional Assessment of Cancer Therapy-Prostate (FACT-P), From beginning of ADT to death	through study completion, an average of 48 months