Stereotactic radiation therapy for high-risk prostate cancer
A Phase II Clinical Study of Stereotactic Radiation Therapy Based on Multiparameter Magnetic Resonance Image in Patients With High-risk Prostate Cancer
This study is testing a new radiation treatment for high-risk prostate cancer patients who haven't had success with regular therapies to see if it can help them better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | Male |
| Sponsor | West China Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT05430737 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness and safety of stereotactic body radiotherapy (SBRT) combined with pelvic radiation and a gross target volume boost for patients with high-risk prostate cancer. The study aims to determine how well this treatment approach works in patients who have not responded to standard therapies. Participants will undergo SBRT based on multiparametric MRI assessments to target their cancer more precisely. The trial is designed for patients who meet specific criteria related to their cancer stage and treatment history.
Who should consider this trial
Good fit: Ideal candidates for this study are men aged 18 and older with pathologically confirmed high-risk prostate cancer who have undergone neoadjuvant androgen deprivation therapy within the last six months.
Not a fit: Patients with distant metastasis or those who have previously received definitive treatment for prostate cancer are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective option for patients with high-risk prostate cancer, potentially improving their outcomes.
How similar studies have performed: While SBRT has shown effectiveness in lower-risk prostate cancer, this specific approach for high-risk patients is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * pathologically confirmed high-risk (T3a or Gleason score ≥ 8 or a PSA \> 20 ng/ml) prostate cancer * a WHO performance status 0-1 * history of neoadjuvant androgen deprivation therapy(ADT) within 6 months before enrollment * Patients with pelvic positive lymph node were also included in our study Exclusion Criteria: * distant metastasis * history of neoadjuvant ADT over 6 months before enrollment * history of definitive treatment for prostate cancer such as radical prostatectomy * history of pelvic irradiation; prostate volume≥100 cm3
Where this trial is running
Chengdu, Sichuan
- China, SiChuan — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Principal investigator: xin wang — China, SiChuan West China Hospital
- Study coordinator: xin wang, PhD/MD
- Email: wangxin213@sina.com
- Phone: +86 28 85423609
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.