Focal Salvage HDR Brachytherapy for the Treatment of Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Sunnybrook Health Sciences Centre
Sponsor:
Collaborator:
Canadian Association of Radiation Oncology
Information provided by (Responsible Party):
Dr. Hans Chung, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01583920
First received: April 20, 2012
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

Radiation therapy is considered a standard treatment option for the management of localized prostate cancer. Among the 20-30% who recur, a proportion of them will present with an isolated local recurrence, meaning no distant metastases. If left untreated, it may serve as a source for subsequent metastases. Salvage options available for isolated local recurrence include; temporary or permanent implantation of radioactive seeds into the prostate, complete removal of the prostate gland, use of low temperatures to treat the disease, and high frequency ultrasound to treat the disease. There are risks of complications associated with all these treatments, and there is presently no consensus as to which treatment is the best. Therefore, the aim of this pilot study is to look at the feasibility and toxicities of focal treatment of the prostate using temporary implantation of radioactive seeds into the prostate which the investigators hope will be less since the entire prostate is not treated.


Condition Intervention Phase
Prostate Cancer
Radiation: focal salvage HDR prostate brachytherapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Focal Salvage HDR Prostate Brachytherapy

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Incidence of acute urinary and rectal toxicities [ Time Frame: Acute period (<6 months) ] [ Designated as safety issue: Yes ]
    Common Terminology Criteria for Adverse Events (CTCAE) v4.0


Secondary Outcome Measures:
  • Incidence of late urinary and rectal toxicities [ Time Frame: Late period (>6 months) ] [ Designated as safety issue: Yes ]
    Common Terminology Criteria for Adverse Events (CTCAE) v4.0

  • Biochemical (ie. prostate specific antigen) disease free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Quality of Life (QoL) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Expanded Prostate Cancer Index Composite (EPIC)

  • Acute and late urinary toxicities [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    American Urological Association Symptom Index Score (i.e. IPSS)


Estimated Enrollment: 10
Study Start Date: July 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Focal salvage HDR prostate brachytherapy Radiation: focal salvage HDR prostate brachytherapy
Treatment will be delivered using 192-Ir HDR afterloading. Dose prescription is 2 fractions of 13.5 Gy each, delivered 1 week apart.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy confirmed locally recurrent prostate adenocarcinoma > 30months after the completion of radiotherapy by a stereotactic transperineal biopsy
  • Staging T2 weighted, DWI and DCE-MRI that demonstrates solitary recurrence confined to prostate, and correlates with stereotactic transperineal biopsy
  • American Urological Association Symptom Index Score (ie. IPSS) < 15
  • Baseline (post radiotherapy) serum PSA < 10 ng/mL
  • Prostate volume as measured by transrectal ultrasound (TRUS) < 50cc
  • ECOG performance status 0-1

Exclusion Criteria:

  • Prior radiotherapy to the prostate that exceeded 78Gy (2Gy fractions)
  • Any of the following prior therapies: transurethral resection of the prostate (TURP), radionuclide (permanent or temporary implantation) prostate brachytherapy, prostatectomy or prostatic cryosurgery, HIFU (hi-intensity focused ultrasound), bilateral orchiectomy, chemotherapy for prostatic carcinoma
  • Evidence of castrate resistance (defined as PSA > 3 ng/mL while testosterone is < 1.7 nmol/L). Patients could have been on combined androgen blockade with initial radiotherapy but are excluded if this was started due to PSA progression.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583920

Contacts
Contact: Hans Chung, MD (416) 480-6100 hans.chung@sunnybrook.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre, Odette Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Hans Chung, MD       hans.chung@sunnybrook.ca   
Principal Investigator: Hans Chung, MD         
Sub-Investigator: Andrew Loblaw, MD         
Sub-Investigator: Gerard Morton, MD         
Sub-Investigator: Masoom Haider, MD         
Sub-Investigator: Ananth Ravi         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Canadian Association of Radiation Oncology
Investigators
Principal Investigator: Hans Chung, MD Sunnybrook Health Sciences Centre, Odette Cancer Centre
  More Information

No publications provided

Responsible Party: Dr. Hans Chung, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01583920     History of Changes
Other Study ID Numbers: clinicaltrials_hchu_042012
Study First Received: April 20, 2012
Last Updated: December 3, 2013
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
prostatic neoplasms
brachytherapy
salvage therapy
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 26, 2014