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MR-linac Guided Ultra-hypofractionated RT for Prostate Cancer (SMART-P01 and SMART-P02)

RECRUITINGN/ASponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Actively Recruiting
PhaseN/A
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
Started2021-02-01
Est. completion2027-12-31
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted

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

Age: 18 Years+Sex: MALEHealthy volunteers accepted
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

Conditions8

Adaptive RadiotherapyCancerLocalised DiseaseMagnetic Resonance-linacOligometastatic DiseaseProstate CancerRadiotherapy Side EffectStereotactic Ablative RT

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