PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer
Recruiting · NCT06392295 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Miami
View the official record on ClinicalTrials.gov →Interventions studied
Androgen Deprivation TherapyAndrogen Receptor Signaling InhibitorPara Aortic Radiation Therapy: Photon TherapyPara Aortic Radiation Therapy: Proton Therapy
What this trial is about
The purpose of this prostate cancer research study is to learn about: 1. Improving control of prostate cancer using radiation therapy, delivered to the para-aortic and pelvic lymph nodes, in addition to systemic androgen suppression therapy; 2. Preserving quality of life after radiation therapy; 3. Leveraging imaging results from prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) scans to evaluate and manage disease progression.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Histologically proven prostate adenocarcinoma
- Male, ≥ 18 years old
- Oligorecurrent disease limited to the sub-diaphragmatic region with or without pelvic lymph nodes
- a. No more than a total of 5 lesions on PSMA PET/CT scan (each lesion defined as positive with standardized uptake value (SUV) \> liver uptake and CT scan correlate)
- b. No disease outside of the pelvic and sub-diaphragmatic para-aortic lymph nodes
- c. At least one lesion in the sub-diaphragmatic pelvic or 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 of the pelvic lymph nodes and/or
- b. Salvage or adjuvant radiation therapy to the prostate bed following prostatectomy 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 of the research study, and willingness to sign the written informed consent and HIPAA document(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 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 or pelvic 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 to staging PSMA PET/CT scan (suggesting oligoprogressive disease, rather than true oligorecurrent disease) or at time of study enrollment
- Suspicious radiologic evidence of disease in the prostate on staging PSMA PET/CT scan without confirmatory negative prostate biopsy
- Implanted hardware which limits treatment planning or delivery (determined by treating physician)
- Castration-resistant prostate cancer (history of rising PSA with serum testosterone level \<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
Where it is running
1 location listed across 1 US state.
- University of Miami - Miami, Florida, United States