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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

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Recurrent Radiation: HDR brachytherapy Phase 1 Phase 2

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.

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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 Whole Gland Salvage HDR Prostate Brachytherapy for Locally Recurrent Prostate Cancer
Study Start Date : August 2014
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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
Radiation: HDR brachytherapy
Whole gland salvage




Primary Outcome Measures :
  1. Acute GI toxicities [ Time Frame: 3 mths post brachytherapy ]
    Acute GI toxicities using NCI CTCAE v4.0

  2. Acute GU toxicities [ Time Frame: 3 moths post brachytherapy ]
    Acute GU toxicities utilizing NCI CTCAE v4.0


Secondary Outcome Measures :
  1. Acute GU symptoms [ Time Frame: 5 years ]
    Acute GU symptoms American Urological Association Symptom Index Score (IPSS)

  2. Late GU symptoms [ Time Frame: 5 years ]
    Late GU symptoms American Urological Association Symptom Index Score (IPSS)

  3. Late GI toxicities [ Time Frame: 5 years ]
    Late GI toxicities using NCI CTCAE v.4.0

  4. Late GU toxicities [ Time Frame: 5 years ]
    Late GU Toxicities using NCI CTCAE v.4.0

  5. Biochemical disease free survival [ Time Frame: 5 years ]
    PSA

  6. Quality of Life (QoL) [ Time Frame: 5 years ]
    QoL measured using Expanded Prostate Cancer Index Composite (EPIC)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02560181


Contacts
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Contact: Hans Chung, MD 416 480 6100 ext 4982 hans.chung@sunnybrook.ca

Locations
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Canada, Ontario
Odette Cancer Centre, Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Hans Chung, MD    416 480 6100 ext 4834    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, PhD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: Hans Chung, MD Odette Cancer Centre, Sunnybrook Health Sciences Centre

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Responsible Party: Dr. Hans Chung, Radiation Oncologist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02560181     History of Changes
Other Study ID Numbers: clinicaltrials_hchu_180-2014
First Posted: September 25, 2015    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

Keywords provided by Dr. Hans Chung, Sunnybrook Health Sciences Centre:
recurrent prostate cancer, HDR whole gland salvage

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