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

NCT03129854 | Recruiting DMC

• 1 other identifier: YoLi
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer Metastatic

Keywords

prostate cancer; metastatic; cryotherapy; ADT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall Survival

  through study completion, an average of 60 months

• prostate cancer specific survival

  through study completion, an average of 60 months

• Functional Assessment of Cancer Therapy-Prostate

  through study completion, an average of 48 months

Study Arms (2)

experimental group

EXPERIMENTAL

Prostate cryotherapy plus ADT

Device: prostate cryotherapy

control group

NO INTERVENTION

standard of care ADT continually

Interventions

prostate cryotherapy DEVICE

prostate cryotherapy added to experimental group within 6 months of ADT

Also known as: prostate cryoablation

experimental group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: Gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 27174537 BACKGROUND

• 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.

  PMID: 24290503 BACKGROUND

• 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.

  PMID: 18817934 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Minghuang Hong, MD

  Sun Yat-sen University

  STUDY DIRECTOR

Central Study Contacts

Yonghong Li, MD

CONTACT

86-20-87343656; liyongh@sysucc.org.cn

Qiuhong Chen, MD

CONTACT

86-20-87343656; chenqh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: One group receive standard of care ADT continually. Another group receive ADT plus prostate cryotherapy

Study Record Dates

• First Submitted: April 16, 2017
• First Posted: April 26, 2017
• Study Start: March 29, 2017
• Primary Completion: January 1, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 7, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)