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

Clinicaltrials.gov ID: NCT06392295
db-list-check Status RECRUITING
b-loader Phase PHASE2
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 34

Conditions

Prostate Cancer, Prostate Adenocarcinoma, Hormone Sensitive Prostate Cancer

Drugs

Androgen Deprivation Therapy, Androgen Receptor Signaling Inhibitor

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Benjamin J Rich, MD

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

Study Plan

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.nnTotal participation duration is up to five years.

  • RADIATION:

    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).
  • RADIATION:

    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).
  • DRUG:

    Androgen Deprivation Therapy

    Description:

    Androgen deprivation therapy will be administered as per standard of care.
  • DRUG:

    Androgen Receptor Signaling Inhibitor

    Description:

    Androgen receptor signaling inhibitor (ARSI) will be administered as per standard of care.

Outcome Measures

Primary Outcome Measures

Progression-free Survival (PFS)

Time Frame: Up to 2 years

Secondary Outcome Measures

Biochemical Failure-Free Survival (FFS)

Time Frame: Up to 2 years

Metastasis-Free Survival

Time Frame: Up to 2 years

Overall Survival (OS)

Time Frame: Up to 2 years

Median Cause Specific Survival

Time Frame: Up to 2 years

Proportion of Participants Undergoing Escalation of Therapy

Time Frame: Up to 2 years

Proportion of Participants Experiencing Cumulative Late Grade u2265 2 Treatment-Related Toxicity

Time Frame: Up to 2 years

Change in Quality of Life Scores: EPIC 26 Short Form

Time Frame: Up to 2 years

Change in Quality of Life Scores: HADS

Time Frame: Up to 2 years

Change in Quality of Life Scores: IPSS

Time Frame: Up to 2 years

Complete Early Response Rate

Time Frame: Up to 2 years

Timeline

  • Last Updated
    July 12, 2024
  • Start Date
    April 30, 2024
  • Today
    January 16, 2025
  • Completion Date ( Estimated )
    August 1, 2029

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