MRI Assisted Focal Boost With HDR Monotherapy for Prostate Cancer Patients (MARS)

MRI Assisted Focal Boost Integrated With HDR Monotherapy Study in Low and Intermediate Risk Prostate Cancer Patients (MARS)

Radiation therapy plays an important role in the management of prostate cancer. In recent years it has become evident that higher doses of radiation are required to optimize disease control. The limiting factor of escalating dose to the prostate is the surrounding normal tissue. Despite advances in escalating radiation therapy, failures still occur in 20-30% of patients most often at the site of the original primary disease. As such there is growing interest in further dose escalating to the area of primary disease burden.The aim of this work is to look at the feasibility and toxicities of an integrated focal boost to whole gland prostate treatment using high dose rate brachytherapy.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: MRI assisted focal boost with HDR monotherapy

Detailed Description

This study is a pilot study of 60 patients look at the toxicities, biochemical and patient reported quality of life outcomes of an MR-integrated focal boost using HDR prostate brachytherapy. Eligible patients for this study will be determined by pre-brachytherapy MRI (DCE, T2 weighted and diffusion weighted) imaging, to identify a dominant intraprostatic lesion. The HDR dose prescription is 19 Gy to the whole gland ad 22.5 Gy to MRI visible lesion delivered in one fraction, assuming that dose constraints to critical organs can be met.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • SunnyBrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Histologically confirmed diagnosis of adenocarcinoma of the prostate
2. Low and Intermediate risk disease defined as T1-T2c, Gleason < 7 and PSA < 20 ng/ml.
3. Prostate volume < 60 cc as determined by US, CT or MRI
4. Ability to undergo MR imaging
5. Provide written informed consent
6. Identified MR nodule (PIRADs 4/5)

Exclusion Criteria:

1. Ineligible for MR imaging due to contraindications
2. Documented nodal or distant metastases
3. Previous pelvic radiotherapy
4. Previous trans-urethral resection of prostate, previous prostatectomy or HIFU
5. Use of androgen deprivation therapy. Use of 5-alpha-reductase inhibitors permitted
6. Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >15
7. Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
8. Significant medical co-morbidity rendering patient unsuitable for general anaesthetic

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MRI assisted HDR monotherapy; HDR monotherapy to the whole prostate gland (19Gy/1) with MRI assisted focal boost to intraprostatic nodule up to 22.5Gy	Radiation: MRI assisted focal boost with HDR monotherapy; Prior to brachytherapy treatment, a multiparametric MRI will be obtained for identification of the dominant intraprostatic lesion (DIL) and fused with the preplanning transrectal ultrasound. A total of 19 Gy will be prescribed to the prostate, organ at risk limits will be observed and up to 22.5 Gy can be delivered to the DIL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute GU and GI toxicities	Measured according to NCI CTCAE v4.0	3mo

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late GU and GI toxicities	Measured according to NCI CTCAE v4.0	5 years
Quality of life changes	Patient reported outcome utilizing Expanded Prostate Index Composite (EPIC)	5 years
Changes in urinary symptoms	Patient reported outcome utilizing International Prostate Symptom Score (IPSS)	5 years
Changes in serum prostate-specific antigen (PSA)		5 years
PSA failure and disease-free survival rates		5 years

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2015
• Primary Completion (Actual): May 30, 2017
• Study Completion (Anticipated): May 13, 2027

Study Registration Dates

• First Submitted: December 3, 2015
• First Submitted That Met QC Criteria: December 3, 2015
• First Posted (Estimate): December 8, 2015

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 12, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: HDR monotherapy; MRI guidance; Intraprostatic lesion; dose paining
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 222-2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED