Status:
ACTIVE_NOT_RECRUITING
Focal Salvage HDR Brachytherapy for Locally Recurrent Prostate Cancer in Patients Treated With Prior Radiotherapy
Lead Sponsor:
Loyola University
Conditions:
Locally Recurrent Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
This purpose of this study is to evaluate the safety and effectiveness of a technique called focal high-dose-rate (HDR) brachytherapy as treatment for prostate cancer that has come back in the prostat...
Detailed Description
The goal of any radiation treatment plan is to achieve maximal disease response with minimal toxicity. HDR brachytherapy offers a promising definitive treatment option in the setting of Locally Recurr...
Eligibility Criteria
Inclusion
- Biopsy proven locally recurrent adenocarcinoma of the prostate after the completion of definitive radiation therapy for initially diagnosed prostate cancer.
- Biopsy must be performed within 182 days of trial registration
- Biopsy should be a standard sextant biopsy AND either a targeted MR/ultrasound guided biopsy or saturation biopsy or both.
- Initial cancer diagnosis that fits these specific criteria:
- Stages T1-T3a
- Nx or N0
- Mx or M0
- Eligible initial definitive radiotherapy modalities include:
- External beam radiotherapy, with photon or proton beam therapy
- Conventional or moderately hypofractionated radiotherapy
- Extremely hypofractionated external beam radiotherapy (Stereotactic body radiation therapy)
- Definitive Brachytherapy:
- Low-dose rate
- High-dose rate
- Locally recurrent disease confined to the prostate +/- seminal vesicles and immediately adjacent tissue, as evaluated by the following:
- History/Physical examination
- Radiographically node negative disease (N0), as defined by CT or MR of pelvis +/- abdomen within 6 months of registration.
- No evidence of bone metastases (M0) on bone scan within 6 months of registration.
- Fluciclovine-PET is encouraged, but not required
- Patients receiving ADT are eligible as long as they meet the other eligibility criteria. However, the duration of all ADT must be documented.
- Current ECOG Performance status Scale 0-2
- Current International Prostate Symptom Score (IPSS) \< 20
- The patient must be medically suitable to receive general anesthesia.
- The patient must be able and willing to sign a study-specific written informed consent form before study entry.
Exclusion
- Preregistration GI or GU toxicity (for any reason) grade ≥ 3 as defined in CTCAE version 4.03. That is, grade ≥ 3 GU or GI toxicity after first course of radiotherapy
- Patients receiving any other investigational agents.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, severely symptomatic congestive heart failure, cardiac arrhythmia, recent myocardial infarction in last 6 months, or psychiatric illness/social situations that could limit compliance with study requirements.
- Patients who have received chemotherapy or immunotherapy within one month prior to study enrollment, other than ADT
Key Trial Info
Start Date :
August 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03312972
Start Date
August 28 2017
End Date
July 31 2026
Last Update
September 24 2025
Active Locations (2)
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1
Loyola University Medical Center
Maywood, Illinois, United States, 60153
2
University of Virginia School of Medicine
Charlottesville, Virginia, United States, 22908