Prostate Cancer Clinical Trial
Official title:
Phase II Prospective Trial of MR-linac Based Stereotactic Ablative Radiotherapy for Patients With Localized and Oligo-metastatic Prostate Cancer
1. To investigate the tolerability of MR-linac based stereotactic ablative radiotherapy (MRL-SBRT)for patients with localized prostate cancer 2. To assess the acute and late toxicities, efficacy and quality of life for patients treated by MRL-SBRT 3. To simulate the dose planning and assess the feasibility of simultaneous-boost for MR-prominent foci 4. To investigate the relationship between the changes of blood and tissue biomarkers and manifestations on mp-MRI pre-/post-MRL-SBRT, to further ascertain the predictive factors of local persisting and/or relapse disease
Status | Recruiting |
Enrollment | 50 |
Est. completion date | January 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age=18 years? - Histology confirmed prostate cancer. - Risk stratification, localised disease including patients with low-risk(cT1-T2a,PSA <10ng/mL,Gleason score=6) who refuse active surveillance, favorable or unfavorable intermediate-risk and selected high-risk(cT2b-T3a or minimally T3b,PSA 10-40ng/mL,Gleason score 7-8) disease. - Oligo-metastatic disease including patients with prostate in-situ and oligometastatic disease (no limit to mets number and organs, with all metastatic foci can be safely treated by radical SBRT dose) - ECOG 0-2 - Postate gland volume =100cc - IPSS score of <18 - Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed Exclusion Criteria: - Contraindications to MRI. - TURP within the past 6 months - Ulcerative colitis, Crohn's Disease, ataxia telangiectasia, or systemic lupus erythematosus - Previous pelvic irradiation - Refuse contraception |
Country | Name | City | State |
---|---|---|---|
China | Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Chinese Academy of Medical Sciences |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Incidence of Acute GU and GI toxicities: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Three months post-MRL-SBRT | |
Secondary | The Incidence of Late toxicities: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | 6-months, 1-year and 2-year | |
Secondary | Quality of life evaluation | Evaluate quality of life of patients by QOL questionnaires at different time points | Every 2 weeks during SBRT and till 8 weeks after RT completion, every 3 months to 2 years and every 6 months to 5 years, and yearly thereafter | |
Secondary | Biochemical-relapse free survival | 2-year |
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