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

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT06392295
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jul 3, 2024
Status verified
Jun 2025
Primary completion
Aug 1, 2027
Completion
Aug 1, 2029

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PSMA-Guided PA-RT Group
    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.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Benjamin J Rich, MD
[email protected]
305-243-4200
Benjamin J Rich, MD (PRINCIPAL_INVESTIGATOR)
Alan Dal Pra, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of Miami· Miami, FL

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