Phase
Condition
Adenocarcinoma
Prostate Cancer, Early, Recurrent
Urologic Cancer
Treatment
Para Aortic Radiation Therapy: Proton Therapy
Para Aortic Radiation Therapy: Photon Therapy
Androgen Receptor Signaling Inhibitor
Clinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically proven prostate adenocarcinoma
Male, ≥ 18 years old
Oligorecurrent disease limited to the sub-diaphragmatic region with or withoutpelvic lymph nodes
a. No more than a total of 5 lesions on PSMA PET/CT scan (each lesion definedas positive with standardized uptake value (SUV) > liver uptake and CT scancorrelate)
b. No disease outside of the pelvic and sub-diaphragmatic para-aortic lymphnodes
c. At least one lesion in the sub-diaphragmatic para-aortic lymph nodes
d. Non-bulky nodal disease (ie, tumor <5 cm)
- Prior pelvic radiation with disease response
a. Definitive radiation therapy to the prostate with or without treatment ofthe pelvic lymph nodes and/or
b. Salvage or adjuvant radiation therapy to the prostate bed followingprostatectomy with or without treatment of the pelvic lymph nodes
Hormone-sensitive prostate cancer
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
Ability to understand the investigational nature, potential risks and benefits ofthe research study, and willingness to sign the written informed consent and HIPAAdocument(s)
Willingness to fill out quality of life and psychosocial forms
Willingness to participate in our institution's Prostate Cancer Database Protocol (ID# 20090767)
Exclusion
Exclusion Criteria:
No pathological diagnosis of prostate adenocarcinoma
Patient has more than 5 sites of metastatic disease
Patient has history of bone and/or visceral metastasis
No evidence of disease in the para-aortic lymph nodes
No staging with PSMA PET/CT scan
History of prior radiation therapy outside the pelvis for prostate cancer
Bulky nodal disease >5 cm in tumor size
Androgen deprivation therapy (ADT) or chemotherapy in the three months prior tostaging PSMA PET/CT scan (suggesting oligoprogressive disease, rather than trueoligorecurrent disease) or at time of study enrollment
Suspicious radiologic evidence of disease in the prostate on staging PSMA PET/CTscan without confirmatory negative prostate biopsy
Implanted hardware which limits treatment planning or delivery (determined bytreating physician)
Castration-resistant prostate cancer (history of rising PSA with serum testosteronelevel <50 ng/dL)
Patients with ECOG performance status > 2
History of inflammatory bowel disease
History of malignancy other than prostate cancer except for non-melanoma skin cancer
Patients unable to consent or are prisoners
Unwilling to fill out quality of life and psychosocial forms
Participants with impaired decision-making capacity
Study Design
Connect with a study center
University of Miami
Miami, Florida 33136
United StatesActive - Recruiting

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