Prostate Cancer MetastaticNCT03129854
Androgen Deprivation Therapy (ADT) Versus ADT Plus Prostate Cryotherapy for Metastatic Prostate Cancer (mPCa)
A study testing prostate cryotherapy in people with Prostate Cancer Metastatic, run by Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer Metastatic
- What is being tested?
- prostate cryotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 29 Mar 2017to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
Yonghong Li, MD, 86-20-87343656, liyongh@sysucc.org.cn
About this study
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
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.
- Conditions
- Prostate Cancer Metastatic
- Being tested
- prostate cryotherapy
- Keywords
- prostate cancer, metastatic, cryotherapy, ADT
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prostate cryotherapyDevice
Also called prostate cryoablation
prostate cryotherapy added to experimental group within 6 months of ADT
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Prostate cryotherapy plus ADT Receives: Device: prostate cryotherapy |
| control group | No intervention | standard of care ADT continually |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate Cancer Progression-Free Survival
Prostate Cancer Progression-Free Survival (PFS), from beginning of ADT to progression of prostate cancer
Measured: through study completion, an average of 48 months
Secondary outcomes (3)
Overall Survival
Overall Survival (OS), from beginning of ADT to death
Measured: through study completion, an average of 60 months
prostate cancer specific survival
prostate cancer specific survival (CSS), from beginning of ADT to death from prostate cancer
Measured: through study completion, an average of 60 months
Functional Assessment of Cancer Therapy-Prostate
Functional Assessment of Cancer Therapy-Prostate (FACT-P), From beginning of ADT to death
Measured: through study completion, an average of 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start29 Mar 2017
- Primary completion1 Jan 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group receive standard of care ADT continually. Another group receive ADT plus prostate cryotherapy
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yonghong Li, Sun Yat-sen University
- Investigators
- Minghuang Hong, MD, Study director, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129854
- Sponsor's protocol ID
- YoLi
- Status last verified
- Jun 2019
- First submitted
- 16 Apr 2017
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 27174537Culp 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 24290503Babaian 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03129854
- Acronym / sponsor ID
- YoLi
- Conditions
- Prostate Cancer Metastatic
- Keywords
- prostate cancer, metastatic, cryotherapy, ADT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 26 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group receive standard of care ADT continually. Another group receive ADT plus prostate cryotherapy
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: prostate cryotherapyProstate cryotherapy plus ADT |
| control group | No intervention | –standard of care ADT continually |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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. )
Key exclusion criteria (10 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prostate cryotherapyAlso: prostate cryoablationprostate cryotherapy added to experimental group within 6 months of ADT | Device | experimental group |
Primary outcome
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
3 secondary outcomes
Overall Survival
Time frame: through study completion, an average of 60 months
prostate cancer specific survival
Time frame: through study completion, an average of 60 months
Functional Assessment of Cancer Therapy-Prostate
Time frame: through study completion, an average of 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- Background: PubMed 27174537Loppenberg 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.
- Background: PubMed 24290503Culp 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.
- Background: PubMed 18817934Babaian 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minghuang Hong, MD study director
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prostate cryotherapy in people with Prostate Cancer Metastatic, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yonghong Li, MD (86-20-87343656, liyongh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate Cancer Progression-Free Survival (time frame: through study completion, an average of 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03129854, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2019.