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

• Sponsor: Sunnybrook Health Sciences Centre (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02623933
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 139.6
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Radiation: MRI assisted focal boost with HDR monotherapy	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: MRI Assisted Focal Boost Integrated With HDR Monotherapy Study in Low and Intermediate Risk Prostate Cancer Patients (MARS)
• Actual Study Start Date: Sep 24, 2015
• Actual Primary Completion Date: May 30, 2017
• Anticipated Study Completion Date: May 13, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Acute GU and GI toxicities [3mo]

   Measured according to NCI CTCAE v4.0

Secondary Outcome Measures

1. Late GU and GI toxicities [5 years]

   Measured according to NCI CTCAE v4.0

2. Quality of life changes [5 years]

   Patient reported outcome utilizing Expanded Prostate Index Composite (EPIC)

3. Changes in urinary symptoms [5 years]

   Patient reported outcome utilizing International Prostate Symptom Score (IPSS)

4. Changes in serum prostate-specific antigen (PSA) [5 years]

5. PSA failure and disease-free survival rates [5 years]

Eligibility Criteria

Criteria

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

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

1. Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease

2. Significant medical co-morbidity rendering patient unsuitable for general anaesthetic

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5

Sponsors and Collaborators

• Sunnybrook Health Sciences Centre

Investigators

• Principal Investigator: Andrew Loblaw, MD, Sunnybrook Health Sciences Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andrew Loblaw, Dr Andrew Loblaw, Sunnybrook Health Sciences Centre
• ClinicalTrials.gov Identifier: NCT02623933
• Other Study ID Numbers: 222-2015
• First Posted: Dec 8, 2015
• Last Update Posted: Jun 14, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Andrew Loblaw, Dr Andrew Loblaw, Sunnybrook Health Sciences Centre: HDR monotherapy; MRI guidance; Intraprostatic lesion; dose paining
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Jun 14, 2022