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Status unknownNCT03129854Updated Jun 7, 2019

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

An interventional study of prostate cryotherapy in Prostate Cancer Metastatic, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to male participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-06-07.

Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
Male
01

Study 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.

Read the detailed description

Ages Eligible for Study: 18 Years and older.

Genders Eligible for Study: Male.

Accepts Healthy Volunteers: No.

02

Conditions studied

  • Prostate Cancer Metastatic

Keywords

  • prostate cancer
  • metastatic
  • cryotherapy
  • ADT
03

In context

Prostatic Neoplasms

6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.

This study's planned enrollment of 250 is above the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,680 studies on the registry; 609 are open to participants now.

Browse Sun Yat-sen University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

  • Experimental
    experimental group

    Prostate cryotherapy plus ADT

    Device: prostate cryotherapy

  • No intervention
    control group

    standard of care ADT continually

Interventions

  • Deviceprostate cryotherapy

    prostate cryotherapy added to experimental group within 6 months of ADT

    Also known as: prostate cryoablation

06

What researchers measure

Primary outcomes

  1. Prostate Cancer Progression-Free Survival

    Prostate Cancer Progression-Free Survival (PFS), from beginning of ADT to progression of prostate cancer

    Time frame: through study completion, an average of 48 months

Secondary outcomes

  1. Overall Survival

    Overall Survival (OS), from beginning of ADT to death

    Time frame: through study completion, an average of 60 months

  2. prostate cancer specific survival

    prostate cancer specific survival (CSS), from beginning of ADT to death from prostate cancer

    Time frame: through study completion, an average of 60 months

  3. Functional Assessment of Cancer Therapy-Prostate

    Functional Assessment of Cancer Therapy-Prostate (FACT-P), From beginning of ADT to death

    Time frame: through study completion, an average of 48 months

07

Study locations

1 of 1 sites recruiting
  • Sun Yat-Sen University Cancer Center
    Guangzhou, Guangdong 510060, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 27174537 ↗
  • 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. PubMed 24290503 ↗
  • 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. PubMed 18817934 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2017 (actual). Primary completion is estimated for Jan 2025, 93 months after the start.

Of 1,018 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 87. This study's planned 93 months is above that.

Counting every sponsor, half of 1,063 studies reached it within 45 months; a quarter within 22 and three quarters within 87.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 16, 2017
First posted
Apr 26, 2017
StartActual
Mar 29, 2017
Primary completionEst.
Jan 1, 2025
CompletionEst.
Jun 30, 2026
Last update
Jun 7, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03129854
Lead sponsor
Sun Yat-sen University
Responsible party
Yonghong Li (Principal Investigator, Sun Yat-sen University) — Principal investigator
First posted
Apr 26, 2017
Start date
Mar 29, 2017
Primary completion
Jan 1, 2025 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Jun 7, 2019

Study contacts

Yonghong Li, MD
Contact
liyongh@sysucc.org.cn
86-20-87343656
Qiuhong Chen, MD
Contact
chenqh@sysucc.org.cn
86-20-87343656
Minghuang Hong, MD
study director · Sun Yat-sen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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