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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 1, 2025

Detailed Description

Ages Eligible for Study: 18 Years and older. Genders Eligible for Study: Male. Accepts Healthy Volunteers: No.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: experimental group
    • Prostate cryotherapy plus ADT
  • No Intervention: control group
    • standard of care ADT continually

Clinical Trial Outcome Measures

Primary Measures

  • Prostate Cancer Progression-Free Survival
    • Time Frame: through study completion, an average of 48 months
    • Prostate Cancer Progression-Free Survival (PFS), from beginning of ADT to progression of prostate cancer

Secondary Measures

  • Overall Survival
    • Time Frame: through study completion, an average of 60 months
    • Overall Survival (OS), from beginning of ADT to death
  • prostate cancer specific survival
    • Time Frame: through study completion, an average of 60 months
    • prostate cancer specific survival (CSS), from beginning of ADT to death from prostate cancer
  • Functional Assessment of Cancer Therapy-Prostate
    • Time Frame: through study completion, an average of 48 months
    • Functional Assessment of Cancer Therapy-Prostate (FACT-P), From beginning of ADT to death

Participating in This Clinical Trial

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

Gender Eligibility: Male

Gender identity

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sun Yat-sen University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yonghong Li, Principal Investigator – Sun Yat-sen University
  • Overall Official(s)
    • Minghuang Hong, MD, Study Director, Sun Yat-sen University
  • Overall Contact(s)
    • Yonghong Li, MD, 86-20-87343656, liyongh@sysucc.org.cn

References

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.

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.

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.

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