Prostate Cancer Clinical Trial

PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer

Summary

The purpose of this prostate cancer research study is to learn about:

Improving control of prostate cancer using radiation therapy, delivered to the para-aortic and pelvic lymph nodes, in addition to systemic androgen suppression therapy;
Preserving quality of life after radiation therapy;
Leveraging imaging results from prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) scans to evaluate and manage disease progression.

View Eligibility Criteria

Eligibility Criteria

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 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 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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

34

Study ID:

NCT06392295

Recruitment Status:

Not yet recruiting

Sponsor:

University of Miami

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There is 1 Location for this study

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University of Miami
Miami Florida, 33136, United States More Info
Benjamin J Rich, MD
Contact
305-243-4200
[email protected]
Benjamin J Rich, MD
Principal Investigator
Alan Dal Pra, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

34

Study ID:

NCT06392295

Recruitment Status:

Not yet recruiting

Sponsor:


University of Miami

How clear is this clinincal trial information?

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