BridgeMD
New treatment option for Prostate Cancer
Official title PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer
ClinicalTrials.gov ID: NCT06392295
What this study is testing
What is Androgen Deprivation Therapy?
Androgen Deprivation Therapy is an investigational medicine, being studied as a potential treatment for prostate cancer.
Also referred to as ADT.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- b. No disease outside of the pelvic and sub-diaphragmatic para-aortic lymph nodes
You likely can't join if
- 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
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.