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MR-linac Guided Ultra-hypofractionated RT for Prostate Cancer

Primary Purpose

Prostate Cancer, Radiotherapy Side Effect, Magnetic Resonance-linac

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

MR-linac

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MR-linac group

Arm Description

Pts received ultra-hypofractionated RT for primary w/o adjacent oligo-metastatic diseases on 1.5-Tesla MR-Linac

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Quality of life evaluation

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

Biochemical-relapse free survival

Full Information

NCT ID

NCT05183074

First Posted

December 2, 2021

Last Updated

December 20, 2021

Sponsor

Chinese Academy of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT05183074

Brief Title

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

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

To investigate the tolerability of MR-linac based stereotactic ablative radiotherapy (MRL-SBRT)for patients with localized prostate cancer To assess the acute and late toxicities, efficacy and quality of life for patients treated by MRL-SBRT To simulate the dose planning and assess the feasibility of simultaneous-boost for MR-prominent foci 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer, Radiotherapy Side Effect, Magnetic Resonance-linac, Stereotactic Ablative RT, Adaptive Radiotherapy, Localised Disease, Oligometastatic Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MR-linac group

Arm Type

Experimental

Arm Description

Pts received ultra-hypofractionated RT for primary w/o adjacent oligo-metastatic diseases on 1.5-Tesla MR-Linac

Intervention Type

Device

Intervention Name(s)

MR-linac

Intervention Description

1.5-Tesla MR-linac based SBRT

Primary Outcome Measure Information:

Title

The Incidence of Acute GU and GI toxicities: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Description

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

Time Frame

Three months post-MRL-SBRT

Secondary Outcome Measure Information:

Title

The Incidence of Late toxicities: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Description

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

Time Frame

6-months, 1-year and 2-year

Title

Quality of life evaluation

Description

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

Time Frame

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

Title

Biochemical-relapse free survival

Time Frame

2-year

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ning-Ning Lu

Phone

+868611804268

Ning-Ning.Lu@hotmail.com

Facility Information:

Facility Name

Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100021

Country

China

Individual Site Status

Recruiting

Facility Contact: