Focal Salvage HDR Brachytherapy for the Treatment of Prostate Cancer

NCT01583920 | Active Not Recruiting

• 1 other identifier: clinicaltrials_hchu_042012
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostatic neoplasms; brachytherapy; salvage therapy; recurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of acute urinary and rectal toxicities

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

  Acute period (<6 months)

Secondary Outcomes (4)

• Incidence of late urinary and rectal toxicities

  Late period (>6 months)

• Biochemical (ie. prostate specific antigen) disease free survival

  5 years

• Quality of Life (QoL)

  5 years

• Acute and late urinary toxicities

  5 years

Study Arms (1)

Focal salvage HDR prostate brachytherapy

EXPERIMENTAL

Radiation: focal salvage HDR prostate brachytherapy

Interventions

focal salvage HDR prostate brachytherapy RADIATION

Treatment will be delivered using 192-Ir HDR afterloading. Dose prescription is 2 fractions of 13.5 Gy each, delivered 1 week apart.

Focal salvage HDR prostate brachytherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Canadian Association of Radiation Oncology: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre, Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

• Paulin G, Morton G, Loblaw A, Tseng CL, Corkum M, Murgic J, Ravi A, Davidson M, Wronski M, Paudel M, Haider M, Deabreu A, Zhang L, Chung HT. Updated results of MR-assisted focal salvage HDR prostate brachytherapy: a prospective study. Radiother Oncol. 2025 Oct;211:111091. doi: 10.1016/j.radonc.2025.111091. Epub 2025 Aug 9.

  PMID: 40789422 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Hans Chung, MD

  Sunnybrook Health Sciences Centre, Odette Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Hans Chung

Study Record Dates

• First Submitted: April 20, 2012
• First Posted: April 24, 2012
• Study Start: July 1, 2012
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

CA (1)