PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer (NCT06392295) | Clinical Trial Compass
RecruitingPhase 2
PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer
United States34 participantsStarted 2024-07-03
Plain-language summary
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 participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically proven prostate adenocarcinoma
. Male, ≥ 18 years old
. Oligorecurrent disease limited to the sub-diaphragmatic region with or without pelvic lymph nodes
. Prior pelvic radiation with disease response
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Willingness to fill out quality of life and psychosocial forms
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