Comparing hormone therapy alone to hormone therapy with cryotherapy for metastatic prostate cancer
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
This study is testing whether adding cryotherapy to hormone therapy can help men with metastatic prostate cancer live longer and have a better quality of life compared to hormone therapy alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Male |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT03129854 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of androgen deprivation therapy (ADT) alone versus ADT combined with prostate cryotherapy in patients diagnosed with metastatic prostate cancer. Participants are randomly assigned to one of the two treatment groups and are monitored until death or withdrawal from the study. The primary goal is to assess prostate cancer progression-free survival, while secondary outcomes include overall survival, prostate cancer-specific survival, and quality of life. Eligible participants must be male, aged 18 or older, and have a confirmed diagnosis of metastatic prostate cancer.
Who should consider this trial
Good fit: Ideal candidates are males aged 18 and older with histologically confirmed metastatic prostate cancer.
Not a fit: Patients with serious comorbidities or those unable to safely undergo cryosurgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that improves survival and quality of life for patients with metastatic prostate cancer.
How similar studies have performed: Other studies have shown promising results with cryotherapy in prostate cancer treatment, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-Sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Yonghong Li, MD
- Email: liyongh@sysucc.org.cn
- Phone: 86-20-87343656
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.