NCT02560181Active, not recruiting
Pilot Study of Whole Gland Salvage HDR Prostate Brachytherapy for Locally Recurrent Prostate Cancer
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% of patients who recur, there is no consensus on the optimal salvage therapy. 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 (cryotherapy), 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. The aim of this pilot study is to look at the feasibility and toxicities of whole gland salvage treatment of the prostate using temporary implantation of radioactive seeds into the prostate.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 17 Sept 2015
- Start date
- Aug 2014
- Primary completion date
- 30 Aug 2027
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT02560181
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From Aug 2014 to the primary completion date, 30 Aug 2027
- 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; TURP, radionuclide prostate brachytherapy, prostatectomy or prostatic cryosurgery, HIFU, bilateral orchiectomy, chemotherapy for prostatic carcinoma
Other illness
- Disease adjacent to the urethra as visible on MRI
Other
- Evidence of castrate resistance (defined as PSA \> 3ng/mL while testosterone is \< 1.7nmol/L) Patients could have been on combined androgen blockade with initial XRT but are excluded if this was started due to PSA progression
Who the study is looking for
- Biopsy confirmed locally recurrent prostate adenocarcinoma \> 30mths after completion of XRT by stereotactic transperineal biopsy
- Staging T2-weighted, DWI- and DCE- MRI that demonstrates recurrence confined to prostate, and correlates with stereotactic transperineal biopsy
- Previous external beam radiotherapy for prostate cancer with standard/conventional fractionation (1.8-2.0 Gy per fraction), or moderate hypofractionation (2.4-3.4 Gy per fraction).
- Staging CT or MRI (abdomen and pelvis) and bone scan are negative for metastases
- IPSS \< 15
- Baseline (post XRT) serum PSA \< 10ng/mL
- Prostate volume as measured by TRUS \< 50cc
- ECOG performance status 0-1
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 |
|---|---|---|---|
| Odette Cancer Centre, Sunnybrook Health Sciences 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.