Focal Therapy for Prostate Cancer - A Pilot Study of Focal Low Dose Rate Brachytherapy

NCT01830166 | Unknown

• 1 other identifier: H12-03268
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This project will develop and evaluate a treatment plan for prostate focal therapy based on low dose rate brachytherapy. The participants entering this study are those suitable for active surveillance. These participants will be monitored with various imaging methods and interventions such as MR elastography, Transrectal ultrasound elastography, PET/CT and transperineal mapping biopsy to determine the extent of cancer and suitable treatments. Those suitable for focal therapy will be offered the option of low dose rate brachytherapy (LDRB) focal therapy in addition to active surveillance or radical therapy. This study will be used to evaluate the long term use of multi-modal, multi-parametric prostate cancer imaging, combining data from MRI, ultrasound and 11C-choline PET/CT. Such methods can be used to eliminate the need for invasive methods such as mapping biopsies.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Constitute Disease Criteria and Appropriate Treatment Plans

  To develop criteria for what constitutes focal disease and treatment plans appropriate for focal LDRB.

  Approximately 4 years; upon study completion

Secondary Outcomes (1)

• Quality of Life

  Approximately 4 years; upon study completion

Other Outcomes (1)

• Treatment Evaluation of LDR-PB

  Approximately 4 years; upon study completion

Study Arms (1)

Low Dose Radiation Focal Brachytherapy

EXPERIMENTAL

Low Dose Radiation Focal Brachytherapy

Radiation: Low Dose Radiation Focal Brachytherapy

Interventions

Low Dose Radiation Focal Brachytherapy RADIATION

Low Dose Radiation Focal Brachytherapy

Low Dose Radiation Focal Brachytherapy

Eligibility Criteria

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

You may qualify if:

• Must be 18 years of age or older
• Must be able to give informed consent
• Histologic diagnosis of prostate adenocarcinoma made on transrectal guided prostate biopsy with no fewer than 6 cores taken
• The prostate cancer is considered suitable for a strategy of active surveillance as well as conventional radical treatment.
• No more than 2 cores from one lobe containing cancer
• Gleason sum no greater than 3+4 =7 in any one core
• Clinical T stage no higher than T2a
• Serum prostate-specific antigen (PSA) no higher than 10 ng/mL
• No previous radiation therapy to the pelvis
• No prior history of malignancy except non-melanoma skin cancer
• Must be suitable for general or spinal anesthesia
• Must not be on coumadin or other anticoagulants
• Must be suitable for multi-parametric MRI scan (excluded are those with significant renal impairment that would preclude the use of contrast agents and may exclude some patients with cardiac pacemaker, wires, or defibrillator; artificial heart valve; brain aneurysm clip; electrical stimulator for nerves or bones; ear or eye implant; implanted drug infusion pump; coil, catheter, or filter in any blood vessel. Some men with metallic prostheses; shrapnel, bullets, or other metal fragments retained in the body may be excluded as well.

You may not qualify if:

• They are unable to participate in an MRI scan.
• They are unable to undergo general or spinal anesthesia.
• They are on anticoagulation therapy (blood thinners).
• They have had previous radiotherapy to the pelvis.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 4E6, 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

• William J Morris, MD

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2013
• First Posted: April 12, 2013
• Study Start: May 1, 2013
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2019
• Last Updated: July 13, 2017

Record last verified: 2017-07

Locations

CA (1)