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

Primary Purpose

Prostate Cancer Recurrent

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
HDR brachytherapy
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer Recurrent focused on measuring recurrent prostate cancer, HDR whole gland salvage

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Odette Cancer Centre, Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

HDR whole gland salvage treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Acute GI toxicities
Acute GI toxicities using NCI CTCAE v4.0
Acute GU toxicities
Acute GU toxicities utilizing NCI CTCAE v4.0

Secondary Outcome Measures

Acute GU symptoms
Acute GU symptoms American Urological Association Symptom Index Score (IPSS)
Late GU symptoms
Late GU symptoms American Urological Association Symptom Index Score (IPSS)
Late GI toxicities
Late GI toxicities using NCI CTCAE v.4.0
Late GU toxicities
Late GU Toxicities using NCI CTCAE v.4.0
Biochemical disease free survival
PSA
Quality of Life (QoL)
QoL measured using Expanded Prostate Cancer Index Composite (EPIC)

Full Information

First Posted
September 17, 2015
Last Updated
May 3, 2022
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02560181
Brief Title
Pilot Study of Whole Gland Salvage HDR Prostate Brachytherapy for Locally Recurrent Prostate Cancer
Official Title
Pilot Study of Whole Gland Salvage HDR Prostate Brachytherapy for Locally Recurrent Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer Recurrent
Keywords
recurrent prostate cancer, HDR whole gland salvage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HDR whole gland salvage treatment
Arm Type
Other
Arm Description
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 Type
Radiation
Intervention Name(s)
HDR brachytherapy
Intervention Description
Whole gland salvage
Primary Outcome Measure Information:
Title
Acute GI toxicities
Description
Acute GI toxicities using NCI CTCAE v4.0
Time Frame
3 mths post brachytherapy
Title
Acute GU toxicities
Description
Acute GU toxicities utilizing NCI CTCAE v4.0
Time Frame
3 moths post brachytherapy
Secondary Outcome Measure Information:
Title
Acute GU symptoms
Description
Acute GU symptoms American Urological Association Symptom Index Score (IPSS)
Time Frame
5 years
Title
Late GU symptoms
Description
Late GU symptoms American Urological Association Symptom Index Score (IPSS)
Time Frame
5 years
Title
Late GI toxicities
Description
Late GI toxicities using NCI CTCAE v.4.0
Time Frame
5 years
Title
Late GU toxicities
Description
Late GU Toxicities using NCI CTCAE v.4.0
Time Frame
5 years
Title
Biochemical disease free survival
Description
PSA
Time Frame
5 years
Title
Quality of Life (QoL)
Description
QoL measured using Expanded Prostate Cancer Index Composite (EPIC)
Time Frame
5 years

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Chung, MD
Organizational Affiliation
Odette Cancer Centre, Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odette Cancer Centre, Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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