Prostate Cancer Metastatic
Conditions
Keywords
prostate cancer, metastatic, cryotherapy, ADT
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.
Detailed description
Ages Eligible for Study: 18 Years and older. Genders Eligible for Study: Male. Accepts Healthy Volunteers: No.
Interventions
DEVICEprostate cryotherapy
prostate cryotherapy added to experimental group within 6 months of ADT
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
One group receive standard of care ADT continually. Another group receive ADT plus prostate cryotherapy
Eligibility
Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prostate Cancer Progression-Free Survival | through study completion, an average of 48 months | Prostate Cancer Progression-Free Survival (PFS), from beginning of ADT to progression of prostate cancer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | through study completion, an average of 60 months | Overall Survival (OS), from beginning of ADT to death |
| prostate cancer specific survival | 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 | through study completion, an average of 48 months | Functional Assessment of Cancer Therapy-Prostate (FACT-P), From beginning of ADT to death |
Countries
China
Contacts
Primary ContactYonghong Li, MD
Backup ContactQiuhong Chen, MD
Outcome results
None listed