Focal Salvage HDR Brachytherapy for the Treatment of Prostate Cancer

Sunnybrook Health Sciences Centre

Status

Active, not recruiting

Conditions

Prostate Cancer

Treatments

Radiation: focal salvage HDR prostate brachytherapy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01583920

clinicaltrials_hchu_042012

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

Male

Ages

18+ years old

Volunteers

No 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.