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Focal Salvage HDR Brachytherapy for the Treatment of Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01583920
Recruitment Status : Recruiting
First Posted : April 24, 2012
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
Canadian Association of Radiation Oncology
Information provided by (Responsible Party):
Dr. Hans Chung, Sunnybrook Health Sciences Centre

Tracking Information
First Submitted Date  ICMJE April 20, 2012
First Posted Date  ICMJE April 24, 2012
Last Update Posted Date April 4, 2019
Study Start Date  ICMJE July 2012
Estimated Primary Completion Date July 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2012)
Incidence of acute urinary and rectal toxicities [ Time Frame: Acute period (<6 months) ]
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01583920 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2012)
  • Incidence of late urinary and rectal toxicities [ Time Frame: Late period (>6 months) ]
    Common Terminology Criteria for Adverse Events (CTCAE) v4.0
  • Biochemical (ie. prostate specific antigen) disease free survival [ Time Frame: 5 years ]
  • Quality of Life (QoL) [ Time Frame: 5 years ]
    Expanded Prostate Cancer Index Composite (EPIC)
  • Acute and late urinary toxicities [ Time Frame: 5 years ]
    American Urological Association Symptom Index Score (i.e. IPSS)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Focal Salvage HDR Brachytherapy for the Treatment of Prostate Cancer
Official Title  ICMJE Pilot Study of Focal Salvage HDR Prostate Brachytherapy
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Focal salvage HDR prostate brachytherapy
Intervention: Radiation: focal salvage HDR prostate brachytherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 3, 2017)
30
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2012)
4
Estimated Study Completion Date  ICMJE July 2028
Estimated Primary Completion Date July 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Biopsy-confirmed locally recurrent prostate adenocarcinoma > 30months after the completion of XRT, SBRT, LDR or HDR brachytherapy boost with XRT, or LDR or HDR brachytherapy as monotherapy 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
  • Staging CT or MRI (abdomen and pelvis) and bone scan are negative for metastases
  • American Urological Association Symptom Index Score (ie. IPSS) < 15
  • Baseline (post-XRT) serum PSA < 10 ng/mL
  • Prostate volume as measured by transrectal ultrasound (TRUS) < 50cc
  • ECOG performance status 0-1

Exclusion Criteria:

  • Any of the following prior therapies: transurethral resection of the prostate (TURP), radionuclide (permanent or temporary implantation) prostate brachytherapy, prostatectomy or prostatic cryosurgery, HIFU (high-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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hans Chung, MD (416) 480-6100 hans.chung@sunnybrook.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01583920
Other Study ID Numbers  ICMJE clinicaltrials_hchu_042012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Hans Chung, Sunnybrook Health Sciences Centre
Study Sponsor  ICMJE Sunnybrook Health Sciences Centre
Collaborators  ICMJE Canadian Association of Radiation Oncology
Investigators  ICMJE
Principal Investigator: Hans Chung, MD Sunnybrook Health Sciences Centre, Odette Cancer Centre
PRS Account Sunnybrook Health Sciences Centre
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP