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Pilot Study of Whole Gland Salvage HDR Prostate Brachytherapy for Locally Recurrent Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02560181
Recruitment Status : Recruiting
First Posted : September 25, 2015
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Hans Chung, Sunnybrook Health Sciences Centre

Tracking Information
First Submitted Date  ICMJE September 17, 2015
First Posted Date  ICMJE September 25, 2015
Last Update Posted Date April 4, 2019
Study Start Date  ICMJE August 2014
Estimated Primary Completion Date August 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2015)
  • Acute GI toxicities [ Time Frame: 3 mths post brachytherapy ]
    Acute GI toxicities using NCI CTCAE v4.0
  • Acute GU toxicities [ Time Frame: 3 moths post brachytherapy ]
    Acute GU toxicities utilizing NCI CTCAE v4.0
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02560181 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2015)
  • Acute GU symptoms [ Time Frame: 5 years ]
    Acute GU symptoms American Urological Association Symptom Index Score (IPSS)
  • Late GU symptoms [ Time Frame: 5 years ]
    Late GU symptoms American Urological Association Symptom Index Score (IPSS)
  • Late GI toxicities [ Time Frame: 5 years ]
    Late GI toxicities using NCI CTCAE v.4.0
  • Late GU toxicities [ Time Frame: 5 years ]
    Late GU Toxicities using NCI CTCAE v.4.0
  • Biochemical disease free survival [ Time Frame: 5 years ]
    PSA
  • Quality of Life (QoL) [ Time Frame: 5 years ]
    QoL measured using Expanded Prostate Cancer Index Composite (EPIC)
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 Pilot Study of Whole Gland Salvage HDR Prostate Brachytherapy for Locally Recurrent Prostate Cancer
Official Title  ICMJE Pilot Study of Whole Gland Salvage HDR Prostate Brachytherapy for Locally Recurrent Prostate Cancer
Brief Summary Radiation therapy is considered a standard treatment option for the management of localized prostate cancer. Among the 20-30% of patients who recur, there is no consensus on the optimal salvage therapy. 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 (cryotherapy), 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. The aim of this pilot study is to look at the feasibility and toxicities of whole gland salvage treatment of the prostate using temporary implantation of radioactive seeds into the prostate.
Detailed Description Radiation therapy is considered a standard treatment option for the management of localized prostate cancer. Among the 20-30% of patients who recur, there is no consensus on the optimal salvage therapy. 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 (cryotherapy), 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. The aim of this pilot study is to look at the feasibility and toxicities of whole gland salvage treatment of the prostate using temporary implantation of radioactive seeds into the prostate. Reports of the efficacy and toxicities of whole gland salvage HDR brachytherapy for local recurrence after external beam radiation therapy are limited to single-institution studies with small sample sizes. Given that our institution has the highest volume of prostate brachytherapy cases in Ontario and that we receive a significant number of referrals from other cancer centres for brachytherapy, this study will aim to add to the literature and help guide salvage therapy practice within our institution.
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 Recurrent
Intervention  ICMJE Radiation: HDR brachytherapy
Whole gland salvage
Study Arms  ICMJE HDR whole gland salvage treatment
Locally recurrent prostate cancer Whole gland HDR brachytherapy administered Whole gland dose=10.5Gy x 2 fractions delivered one week apart GTV dose=13.5Gy x 2 fractions delivered one week apart
Intervention: Radiation: HDR 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 31, 2017)
30
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2015)
15
Estimated Study Completion Date  ICMJE August 2024
Estimated Primary Completion Date August 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Biopsy confirmed locally recurrent prostate adenocarcinoma > 30mths after completion of XRT by stereotactic transperineal biopsy
  • Staging T2-weighted, DWI- and DCE- MRI that demonstrates recurrence confined to prostate, and correlates with stereotactic transperineal biopsy
  • Previous external beam radiotherapy for prostate cancer with standard/conventional fractionation (1.8-2.0 Gy per fraction), or moderate hypofractionation (2.4-3.4 Gy per fraction).
  • Staging CT or MRI (abdomen and pelvis) and bone scan are negative for metastases
  • IPSS < 15
  • Baseline (post XRT) serum PSA < 10ng/mL
  • Prostate volume as measured by TRUS < 50cc
  • ECOG performance status 0-1

Exclusion Criteria:

  • Disease adjacent to the urethra as visible on MRI
  • Any of the following prior therapies; TURP, radionuclide prostate brachytherapy, prostatectomy or prostatic cryosurgery, HIFU, bilateral orchiectomy, chemotherapy for prostatic carcinoma
  • Evidence of castrate resistance (defined as PSA > 3ng/mL while testosterone is < 1.7nmol/L) Patients could have been on combined androgen blockade with initial XRT but are excluded if this was started due to PSA progression
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hans Chung, MD 416 480 6100 ext 4982 hans.chung@sunnybrook.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02560181
Other Study ID Numbers  ICMJE clinicaltrials_hchu_180-2014
Has Data Monitoring Committee Yes
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 Not Provided
Investigators  ICMJE
Principal Investigator: Hans Chung, MD Odette Cancer Centre, Sunnybrook Health Sciences 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