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Phase II Prospective Trial of MR-linac Based Stereotactic Ablative Radiotherapy for Patients With Localized (SAMRT-P01) and Oligo-metastatic (SMART-P02) Prostate Cancer

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
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• 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

Locations
Other Locations
China
Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences
RECRUITING
Beijing
Contact Information
Primary
Ning-Ning Lu
Ning-Ning.Lu@hotmail.com
+868611804268
Time Frame
Start Date: 2021-02-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 50
Treatments
Experimental: MR-linac group
Pts received ultra-hypofractionated RT for primary w/o adjacent oligo-metastatic diseases on 1.5-Tesla MR-Linac
Related Therapeutic Areas
Sponsors
Leads: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

This content was sourced from clinicaltrials.gov