Back to results

Focal Salvage HDR Brachytherapy for the Treatment of Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Active

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

focal salvage HDR prostate brachytherapy

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostatic neoplasms, brachytherapy, salvage therapy, recurrent prostate cancer

Eligibility Criteria

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

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.

Sites / Locations

Sunnybrook Health Sciences Centre, Odette Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Focal salvage HDR prostate brachytherapy

Arm Description

Outcomes

Primary Outcome Measures

Incidence of acute urinary and rectal toxicities

Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Secondary Outcome Measures

Incidence of late urinary and rectal toxicities

Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Biochemical (ie. prostate specific antigen) disease free survival

Quality of Life (QoL)

Expanded Prostate Cancer Index Composite (EPIC)

Acute and late urinary toxicities

American Urological Association Symptom Index Score (i.e. IPSS)

Full Information

NCT ID

NCT01583920

First Posted

April 20, 2012

Last Updated

May 3, 2022

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Canadian Association of Radiation Oncology

1. Study Identification

Unique Protocol Identification Number

NCT01583920

Brief Title

Focal Salvage HDR Brachytherapy for the Treatment of Prostate Cancer

Official Title

Pilot Study of Focal Salvage HDR Prostate Brachytherapy

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 2012 (undefined)

Primary Completion Date

July 2028 (Anticipated)

Study Completion Date

July 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Canadian Association of Radiation Oncology

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

prostatic neoplasms, brachytherapy, salvage therapy, recurrent prostate cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Focal salvage HDR prostate brachytherapy

Arm Type

Experimental

Intervention Type

Radiation

Intervention Name(s)

focal salvage HDR prostate brachytherapy

Intervention Description

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 Measure Information:

Title

Incidence of acute urinary and rectal toxicities

Description

Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Time Frame

Acute period (<6 months)

Secondary Outcome Measure Information:

Title

Incidence of late urinary and rectal toxicities

Description

Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Time Frame

Late period (>6 months)

Title

Biochemical (ie. prostate specific antigen) disease free survival

Time Frame

5 years

Title

Quality of Life (QoL)

Description

Expanded Prostate Cancer Index Composite (EPIC)

Time Frame

5 years

Title

Acute and late urinary toxicities

Description

American Urological Association Symptom Index Score (i.e. IPSS)

Time Frame

5 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hans Chung, MD

Organizational Affiliation

Sunnybrook Health Sciences Centre, Odette Cancer Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sunnybrook Health Sciences Centre, Odette Cancer Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Focal Salvage HDR Brachytherapy for the Treatment of Prostate Cancer

We'll reach out to this number within 24 hrs