Focal Salvage HDR Brachytherapy for the Treatment of Prostate Cancer

Pilot Study of Focal Salvage HDR Prostate Brachytherapy

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: focal salvage HDR prostate brachytherapy

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre, Odette Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of acute urinary and rectal toxicities	Common Terminology Criteria for Adverse Events (CTCAE) v4.0	Acute period (<6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of late urinary and rectal toxicities	Common Terminology Criteria for Adverse Events (CTCAE) v4.0	Late period (>6 months)
Biochemical (ie. prostate specific antigen) disease free survival		5 years
Quality of Life (QoL)	Expanded Prostate Cancer Index Composite (EPIC)	5 years
Acute and late urinary toxicities	American Urological Association Symptom Index Score (i.e. IPSS)	5 years

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Canadian Association of Radiation Oncology
• Investigators: Principal Investigator: Hans Chung, MD, Sunnybrook Health Sciences Centre, Odette Cancer Centre

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: April 20, 2012
• First Submitted That Met QC Criteria: April 23, 2012
• First Posted (Estimated): April 24, 2012

Study Record Updates

• Last Update Posted (Actual): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: recurrent prostate cancer; brachytherapy; salvage therapy; prostatic neoplasms
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: clinicaltrials_hchu_042012