PSMA-Directed Para-Aortic Radiation Therapy for Oligorecu... | NCT06392295

NCT06392295

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PSMA-Guided PA-RT Group	Experimental	Participants in this group will undergo up to six months of systemic androgen deprivation therapy (ADT) and Androgen receptor signaling inhibitor (ARSI). During system therapy, participants will undergo five weeks of para-aortic radiation therapy. Total participation duration is up to five years.	Radiation: Para Aortic Radiation Therapy: Photon Therapy Radiation: Para Aortic Radiation Therapy: Proton Therapy Drug: Androgen Deprivation Therapy Drug: Androgen Receptor Signaling Inhibitor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Para Aortic Radiation Therapy: Photon Therapy	Radiation	Participants will undergo five weeks of PA-RT daily, for up to 30 minutes per day for 25 days, Monday through Friday, consisting of a total dose of 50 grays (Gys) delivered in 25 fractions to the Clinical Tumor Volume (CTV).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS)	Progression-free survival (PFS) among participants will be assessed during treatment and clinical follow-up. PFS is defined as the time from start of treatment until any of the following: Biochemical failure, escalation of therapy, radiological evidence of disease progression or death of any cause. Radiological evidence of disease progression will be assessed by the treating physician using the Response Evaluation Criteria in prostate-specific membrane antigen (PSMA) PET/CT (RECIP) version 1.0.	Up to 2 years

Secondary Outcomes

Measure	Description	Time Frame
Biochemical Failure-Free Survival (FFS)	Biochemical failure-free survival among participants will be assessed during treatment and clinical follow-up. Biochemical failure-free survival is defined as the time from study enrollment to time of biochemical failure. Biochemical failure, as adapted from the Prostate Cancer Working Group 2 (PCWG2), is defined as when prostate-specific antigen (PSA) level increases ≥ 25% and ≥ 2 ng/mL above the nadir, which is confirmed by a second value obtained three or more weeks later.

Eligibility Module

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 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

Name	Role	Phone	Extension	Email
Benjamin J Rich, MD	Contact	305-243-4200		brich@miami.edu
Alan Dal Pra, MD	Contact	305-243-4200		alan.dalpra@med.miami.edu

ID	Term
D006727	Hormone Antagonists
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses