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Phase II prospective trial for MR-linac based stereotactic ablative radiotherapy for patients with localized prostate cancer

Phase II prospective trial for MR-linac based stereotactic ablative radiotherapy for patients with localized prostate cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033382
Enrollment
Unknown
Registered
2020-05-30
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer

Interventions

Single-arm:SBRT

Sponsors

Cancer Hospital of Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients over 18 years old; 2. Patients with primary prostate cancer confirmed by pathology; 3. Risk stratification: Patients with low risk (ct1-t2a, PSA < 10NG / ml, Gleason score <=6) who refuse to actively monitor patients or patients with good / bad prognosis and some high risk (ct2b-t3a, PSA 10-40ng / ml, Gleason score 7-8) who refuse to actively monitor patients; 4. Patients with ECoG score of 0-2; 5. Prostate volume <=100cc; 6. Patients with IPSS score <18; 7. Patients who fully understand this study, can complete all treatment, have follow-up conditions and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications of MRI; 2. Patients who received transurethral prostatectomy within 6 months; 3. Image staging shows n + or M0; 4. Patients with ulcerative colitis, Crohn's disease, ataxia telangiectasia or systemic lupus erythematosus; 5. Patients with previous radiotherapy of pelvic cavity or prostate and surrounding organs; 6. Patients with new cancer within 5 years (except for early skin basal cell carcinoma); 7. Patients who had started endocrine therapy before entering the group; 8. Objects with fertility but refusing contraception; 9. Patients participating in other clinical trials at present or within four weeks before inclusion.

Design outcomes

Primary

MeasureTime frame
Acute GU and GI toxicities;

Secondary

MeasureTime frame
Late toxicities;Quality of Life;2-year biochemical-relapse free survival;

Countries

China

Contacts

Public ContactNingning Lu/ Nianzeng Xing/ Yexiong Li

Cancer Hospital of Chinese Academy of Medical Sciences

ningninglu09@163.com+86 10-87787639

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026