MRI Assisted Focal Boost With HDR Monotherapy for Prostate Cancer Patients

NCT02623933 | Active Not Recruiting

• 1 other identifier: 222-2015
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

HDR monotherapy; MRI guidance; Intraprostatic lesion; dose paining

Outcome Measures

Primary Outcomes (1)

• Acute GU and GI toxicities

  Measured according to NCI CTCAE v4.0

  3mo

Secondary Outcomes (5)

• Late GU and GI toxicities

  5 years

• Quality of life changes

  5 years

• Changes in urinary symptoms

  5 years

• Changes in serum prostate-specific antigen (PSA)

  5 years

• PSA failure and disease-free survival rates

  5 years

Study Arms (1)

MRI assisted HDR monotherapy

EXPERIMENTAL

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

Interventions

MRI assisted focal boost with HDR monotherapy RADIATION

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

MRI assisted HDR monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Andrew Loblaw, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Andrew Loblaw

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 8, 2015
• Study Start: September 24, 2015
• Primary Completion: May 30, 2017
• Study Completion (Estimated): May 13, 2027
• Last Updated: June 14, 2022

Record last verified: 2022-06

Locations

CA (1)