Prostate Cancer - Recurrent Clinical Trial
Official title:
BEACON - A Phase I/II Study of High-dose-rate Brachytherapy and External Beam and Short-term Androgen Deprivation COmbined for the Treatment of Men With Fluciclovine PET Pelvic Nodal Uptake in Locally Recurrent Prostate Cancer After Prior Definitive Radiotherapy
The purpose of this study is to evaluate the safety and effectiveness of combining high-dose-rate (HDR) brachytherapy with external beam radiotherapy (EBRT) to the pelvis and 6 months of hormonal therapy, otherwise known as short term androgen deprivation therapy (STAD), as treatment for prostate cancer that has come back in the prostate and pelvic lymph nodes after prior radiotherapy. The study will examine the side effects of the treatment as well as the ability of the treatment to get rid of the cancer. This involves the placement of a radioactive material in the affected area of the prostate temporarily, and then is subsequently removed using a minimally invasive technique. Participants will also receive external radiation for 5 weeks targeting the pelvis and giving a higher dose each day to the suspicious lymph nodes on PET scan. Radiation therapy will start approximately 2 months after the start of the Androgen Deprivation Therapy (hormone therapy). The hormone therapy consists of two medications, an oral medication taken daily 2 months before starting radiation therapy until the last of the radiation therapy and an injection of a medication which is given 2 months prior to the start of radiation. Patient are then followed at specific time intervals to evaluate the treatment side effects and cancer control
Salvage regional and local radiation is frequently utilized across multiple disease sites in
oncology for patients who have failed initial radiotherapy. However, in prostate cancer, due
to the concern that nodal involvement is a manifestation of widespread distant disease, this
type of approach has not typically been pursued. However, with newer imaging modalities such
as fluciclovine PET, PSMA pet, and C11 PET, physicians are identifying nodal disease and
excluding distant disease better than they ever have before. Thus, in the modern era regional
control may translate to improved long-term biochemical control, and prevent the morbidity
and mortality associated with clinical progression of recurrent prostate cancer
Thus, in patients who recur both in the prostate and in the pelvic lymph nodes, treating both
with radiation could result in meaningful clinical efficacy for patients—similar to other
disease sites. However, there are limited data exploring the feasibility and safety of this
combination. Therefore, the investigators are conducting this trial, which combines salvage
HDR brachytherapy to the local recurrence of the prostate cancer with EBRT to the pelvic
lymph nodes, and short-term hormonal therapy, in this group of patients. The investigators
hypothesize that this approach can safely be performed without excess toxicity.
Once a patient is deemed eligible for the study and has signed the informed consent form, the
patient will start hormone therapy with a LHRH Agonist medication which is an intramuscular
injection which patients will receive every 3-6 months for 6 months. Within 10 days of the
LHRH injection the patient must start an anti-androgen pill and will take the pill once a day
until the last day of radiation. Radiation Therapy will start approximate 2 months after the
start of the hormone therapy. Patients will undergo 2 implants with 1 fraction of 12 Gy
delivered with each implant, scheduled 1-2 weeks apart when possible, although longer or
shorter intervals are acceptable with PI approval. The implant procedure will be done under
general anesthesia. Patients will also receive the external beam radiotherapy (for 5 weeks),
starting before or after the brachytherapy treatment. Patients will also be asked to complete
2 short quality of life questionnaires before they receive treatment and at follow up visits.
Patient will follow up with the radiation oncologist for an exam at 1 month, 3 months, 6
months and 12 months after treatment and then every 6 months for 4 more years then annually
thereafter.
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