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Trial Title:
PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer
NCT ID:
NCT06392295
Condition:
Prostate Cancer
Prostate Adenocarcinoma
Hormone Sensitive Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Ascorbic Acid
Methyltestosterone
Androgens
Estrogens, Conjugated (USP)
Conditions: Keywords:
Oligorecurrent Disease
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Para Aortic Radiation Therapy: Photon Therapy
Description:
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).
Arm group label:
PSMA-Guided PA-RT Group
Other name:
PA-RT Photon Therapy
Intervention type:
Radiation
Intervention name:
Para Aortic Radiation Therapy: Proton Therapy
Description:
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 60 to 65 Gys delivered in 25
fractions to the Gross Tumor Volume (GTVn).
Arm group label:
PSMA-Guided PA-RT Group
Other name:
PA-RT Proton Therapy
Intervention type:
Drug
Intervention name:
Androgen Deprivation Therapy
Description:
Androgen deprivation therapy will be administered as per standard of care.
Arm group label:
PSMA-Guided PA-RT Group
Other name:
ADT
Intervention type:
Drug
Intervention name:
Androgen Receptor Signaling Inhibitor
Description:
Androgen receptor signaling inhibitor (ARSI) will be administered as per standard of
care.
Arm group label:
PSMA-Guided PA-RT Group
Other name:
ARSI
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histologically proven prostate adenocarcinoma
2. Male, ≥ 18 years old
3. 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)
4. 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
5. Hormone-sensitive prostate cancer
6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
7. 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)
8. Willingness to fill out quality of life and psychosocial forms
9. Willingness to participate in our institution's Prostate Cancer Database Protocol
(ID# 20090767)
Exclusion Criteria:
1. No pathological diagnosis of prostate adenocarcinoma
2. Patient has more than 5 sites of metastatic disease
3. Patient has history of bone and/or visceral metastasis
4. No evidence of disease in the para-aortic lymph nodes
5. No staging with PSMA PET/CT scan
6. History of prior radiation therapy outside the pelvis for prostate cancer
7. Bulky nodal disease >5 cm in tumor size
8. 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
9. Suspicious radiologic evidence of disease in the prostate on staging PSMA PET/CT
scan without confirmatory negative prostate biopsy
10. Implanted hardware which limits treatment planning or delivery (determined by
treating physician)
11. Castration-resistant prostate cancer (history of rising PSA with serum testosterone
level <50 ng/dL)
12. Patients with ECOG performance status > 2
13. History of inflammatory bowel disease
14. History of malignancy other than prostate cancer except for non-melanoma skin cancer
15. Patients unable to consent or are prisoners
16. Unwilling to fill out quality of life and psychosocial forms
17. Participants with impaired decision-making capacity
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Benjamin J Rich, MD
Phone:
305-243-4200
Email:
brich@miami.edu
Investigator:
Last name:
Benjamin J Rich, MD
Email:
Principal Investigator
Investigator:
Last name:
Alan Dal Pra, MD
Email:
Principal Investigator
Start date:
July 3, 2024
Completion date:
August 1, 2029
Lead sponsor:
Agency:
University of Miami
Agency class:
Other
Source:
University of Miami
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06392295
