Focal Salvage HDR Brachytherapy for the Treatment of Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Pilot Study of Focal Salvage HDR Prostate Brachytherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01583920
• Other study ID #: clinicaltrials_hchu_042012
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2012
• Est. completion date: July 2028

Study information

• Verified date: November 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: July 2028
• Est. primary completion date: July 2028
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre, Odette Cancer Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Canadian Association of Radiation Oncology

Country where clinical trial is conducted

Canada, 

Outcome

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