MRI Assisted Focal Boost With HDR Monotherapy for Prostate Cancer Patients

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: MRI assisted focal boost with HDR monotherapy

• Registration Number: NCT02623933
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-09-24
• Study First Submitted: 2015-12-03
• Study First Submitted QC: 2015-12-03
• Study First Posted: 2015-12-08
• Primary Completion: 2017-05-30
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-12
• Last Update Posted: 2022-06-14
• Study Completion: 2027-05-13

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 60

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI assisted HDR monotherapy	MRI assisted focal boost with HDR monotherapy	HDR monotherapy to the whole prostate gland (19Gy/1) with MRI assisted focal boost to intraprostatic nodule up to 22.5Gy

Primary Outcome Measures

Name	Time	Method
Acute GU and GI toxicities	3mo	Measured according to NCI CTCAE v4.0

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada