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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 : February 19, 2018
Sponsor:
Collaborator:
Canadian Association of Radiation Oncology
Information provided by (Responsible Party):
Dr. Hans Chung, Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: focal salvage HDR prostate brachytherapy Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Focal Salvage HDR Prostate Brachytherapy
Study Start Date : July 2012
Estimated Primary Completion Date : July 2028
Estimated Study Completion Date : July 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
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.



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


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

  2. Biochemical (ie. prostate specific antigen) disease free survival [ Time Frame: 5 years ]
  3. Quality of Life (QoL) [ Time Frame: 5 years ]
    Expanded Prostate Cancer Index Composite (EPIC)

  4. Acute and late urinary toxicities [ Time Frame: 5 years ]
    American Urological Association Symptom Index Score (i.e. IPSS)



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

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.

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): 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

Responsible Party: Dr. Hans Chung, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01583920     History of Changes
Other Study ID Numbers: clinicaltrials_hchu_042012
First Posted: April 24, 2012    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018

Keywords provided by Dr. Hans Chung, 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