Clinical trial NCT05183074: MR-linac Guided Ultra-hypofractionated RT for Prostate Cancer
Official title: Phase II Prospective Trial of MR-linac Based Stereotactic Ablative Radiotherapy for Patients With Localized and Oligo-metastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Radiotherapy Side Effect
Magnetic Resonance-linac
Stereotactic Ablative RT
Adaptive Radiotherapy
Localised Disease
Oligometastatic Disease
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2022-01-10
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: The Incidence of Acute GU and GI toxicities: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: Three months post-MRL-SBRT
Secondary outcomes:
measure: The Incidence of Late toxicities: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: 6-months, 1-year and 2-year
measure: Quality of life evaluation
timeFrame: 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
measure: Biochemical-relapse free survival
timeFrame: 2-year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References: