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
• Biopsy proven locally recurrent adenocarcinoma of the prostate after the completion of definitive radiation therapy for initially diagnosed prostate cancer.
• Initial cancer diagnosis that fits these specific criteria:
• Stages cT1-T3a
• Nx or N0
• Mx or M0
• Eligible initial definitive radiotherapy modalities include:
• External beam radiotherapy, with photon or proton beam therapy
• Definitive Brachytherapy
• Stereotactic Body Radiotherapy
• Fluciclovine-positive pelvic nodes (as determined by an interpreting radiologist or nuclear medicine physician) in the pelvic nodal region (defined as the pelvic nodal regions up to the common iliac nodal region) without any evidence of lymph node involvement outside of this area or distant metastases
• Candidate for hormonal therapy.
• Current ECOG Performance status Scale 0-2 (Appendix D)
• Current International Prostate Symptom Score (IPSS) < 20 (Appendix B)
• Age >18
• The patient must be medically suitable to receive general or spinal anesthesia.
• AST, ALT, and alkaline phosphatase < 2 x upper institutional limit within 3 months of registration.
• The patient must be able and willing to sign a study-specific written informed consent form before study entry.