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

ConditionsProstate CancerProstate AdenocarcinomaHormone Sensitive Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Miami

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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).

  • Para Aortic Radiation Therapy: Proton 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 60 to 65 Gys delivered in 25 fractions to the Gross Tumor Volume (GTVn).

  • Androgen Deprivation Therapy

    Drug

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

  • Androgen Receptor Signaling Inhibitor

    Drug

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

Treatment groups

34 Participants
are divided into 1 treatment group
Group A: PSMA-Guided PA-RT GroupExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 2 years

Secondary outcomes

1

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.

Time frame
Up to 2 years
2

Metastasis-Free Survival

Metastasis-free survival among participants will be assessed during treatment and clinical follow-up. Metastasis-free survival is defined as the time from study enrollment to clinical or radiological evidence of metastatic disease or death.

Time frame
Up to 2 years
3

Overall Survival (OS)

Overall survival (OS) among participants will be assessed. OS is defined as the time from study enrollment to death of any cause.

Time frame
Up to 2 years
4

Median Cause Specific Survival

Median case specific survival among participants will be assessed. Median cause specific survival is defined as the time from study enrollment to death secondary to prostate cancer.

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

Source ClinicalTrials.gov
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