MR-linac Guided Ultra-hypofractionated RT for Prostate Cancer

• Sponsor: Chinese Academy of Medical Sciences (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05183074
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 35.9
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Radiotherapy Side Effect; Magnetic Resonance-linac; Stereotactic Ablative RT; Adaptive Radiotherapy; Localised Disease; Oligometastatic Disease	Device: MR-linac	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Prospective Trial of MR-linac Based Stereotactic Ablative Radiotherapy for Patients With Localized and Oligo-metastatic Prostate Cancer
• Actual Study Start Date: Feb 1, 2021
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Jan 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MR-linac group Pts received ultra-hypofractionated RT for primary w/o adjacent oligo-metastatic diseases on 1.5-Tesla MR-Linac	Device: MR-linac; 1.5-Tesla MR-linac based SBRT

Outcome Measures

Primary Outcome Measures

1. The Incidence of Acute GU and GI toxicities: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Three months post-MRL-SBRT]

   Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Secondary Outcome Measures

1. The Incidence of Late toxicities: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [6-months, 1-year and 2-year]

   Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

2. Quality of life evaluation [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]

   Evaluate quality of life of patients by QOL questionnaires at different time points

3. Biochemical-relapse free survival [2-year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing	China	100021

Sponsors and Collaborators

• Chinese Academy of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ning-Ning Lu, Principle Investigator, Chinese Academy of Medical Sciences
• ClinicalTrials.gov Identifier: NCT05183074
• Other Study ID Numbers: NCC2277
• First Posted: Jan 10, 2022
• Last Update Posted: Jan 10, 2022
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Jan 10, 2022