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

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ClinicalTrials.gov Identifier: NCT01830166
Recruitment Status : Unknown
Verified July 2017 by British Columbia Cancer Agency.
Recruitment status was:  Active, not recruiting
First Posted : April 12, 2013
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
British Columbia Cancer Agency

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Low Dose Radiation Focal Brachytherapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: FTPC (Focal Therapy for Prostate Cancer): A Pilot Study Using Focal Low Dose Rate Brachytherapy as an Alternative to Active Surveillance and Radical Treatment for Favourable Risk Prostate Cancer.
Study Start Date : May 2013
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Low Dose Radiation Focal Brachytherapy
Low Dose Radiation Focal Brachytherapy
Radiation: Low Dose Radiation Focal Brachytherapy
Low Dose Radiation Focal Brachytherapy




Primary Outcome Measures :
  1. Constitute Disease Criteria and Appropriate Treatment Plans [ Time Frame: Approximately 4 years; upon study completion ]
    To develop criteria for what constitutes focal disease and treatment plans appropriate for focal LDRB.


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: Approximately 4 years; upon study completion ]
    To show that patients undergoing focal therapy have a better quality of life than those undergoing radical therapy while having similar long term oncologic outcomes.


Other Outcome Measures:
  1. Treatment Evaluation of LDR-PB [ Time Frame: Approximately 4 years; upon study completion ]
    To correlate multi-modal, multi-parametric imaging results with the results of mapping biopsies with the goal of developing image-based techniques for patient selection and monitoring the efficacy of focal LDRB.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01830166


Locations
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Canada, British Columbia
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
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Principal Investigator: William J Morris, MD British Columbia Cancer Agency

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Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT01830166     History of Changes
Other Study ID Numbers: H12-03268
First Posted: April 12, 2013    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases