Focal Salvage HDR Brachytherapy for Locally Recurrent Prostate Cancer in Patients Treated With Prior Radiotherapy

Inclusion Criteria:

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 Criteria:

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