MRI Assisted Focal Boost With HDR Monotherapy for Prostate Cancer Patients

Prostate Cancer Clinical Trial

— MARS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02623933
• Other study ID #: 222-2015
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 24, 2015
• Est. completion date: May 13, 2027

Study information

• Verified date: June 2022
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: May 13, 2027
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute GU and GI toxicities	Measured according to NCI CTCAE v4.0	3mo
Secondary	Late GU and GI toxicities	Measured according to NCI CTCAE v4.0	5 years
Secondary	Quality of life changes	Patient reported outcome utilizing Expanded Prostate Index Composite (EPIC)	5 years
Secondary	Changes in urinary symptoms	Patient reported outcome utilizing International Prostate Symptom Score (IPSS)	5 years
Secondary	Changes in serum prostate-specific antigen (PSA)		5 years
Secondary	PSA failure and disease-free survival rates		5 years