NCT01583920Active, not recruiting
Focal Salvage HDR Brachytherapy for the Treatment of Prostate Cancer
Pilot Study of Focal Salvage HDR Prostate Brachytherapy
Source: ClinicalTrials.gov · Last updated 27 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 20 Apr 2012
- Start date
- Jul 2012
- Primary completion date
- Jul 2028
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Diseases
- Prostate cancer
- NCT number
- NCT01583920
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From Jul 2012 to the primary completion date, Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunnybrook Health Sciences Centre - Odette Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.