Response With Interim PSMA PET in Metastatic Castration-sensitive Prostate Cancer for Optimization of Adaptive Metastasis-directed Radiotherapy Delivery

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT07674771
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Castrate Sensitive Prostate Cancer
  • Metastasis Castration Resistant Prostate Cancer(mCRPC)
  • Prostate Cancer

Eligibility Criteria

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

Interventions

  • Drug: 68-Ga PSMA11 — DRUG
    0-3 months since initiation of ADT. Baseline PSMA PET imaging. 4-20 sites of metastasis by PSMA PET Will be injected/assessed in line with its FDA label. Other Name:
  • Adaptive stereotactic ablative radiotherapy (SABR) — RADIATION
    Pre-plan 5 fraction SABR 35-40 Gy. SOC systemic therapy allows for ADT and ARSI intensification. Delivery of 3 pulses to all sites. Pulses delivered weekly.
  • 68Ga-PSMA-11 — DRUG
    Repeat PSMA PET imaging at 6 months post-ADT initiation. Radiation of primary allows. Will be injected/assessed in line with its FDA label.
  • Adaptive stereotactive ablative radiotherapy (SABR) — RADIATION
    Delivery of 2 additional pulses to all remaining PSMA PET visible sites

Study Details

The purpose of this study is to characterize the reduction in PSMA-avid tumor volume and metastasis-directed radiotherapy treatment intensity facilitated by PET PSMA-response adapted SABR for poly-metastatic castration sensitive prostate cancer.

Key Dates

Start date
Jul 15, 2026
Status verified
Jun 2026
Primary completion
Jun 15, 2029
Completion
Jun 15, 2029

Study Design

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

Arms

  • Experimental: SINGLE ARM UNBLINDED SINGLE SITE PILOT
    Study will enroll patients with poly-metastatic hormone-sensitive prostate cancer, as identified by baseline PSMA PET imaging.Patients will undergo standard of care systemic therapy,including ADT \& androgen receptor signaling inhibitors intensification as clinically indicated,for up to 3 months before protocol radiotherapy.

Primary Outcome Measure

Reduction in PSMA-positive TTV [ Time Frame: 1 YEAR ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390
SARAH NEUFELD, SUPERVISOR OF CLINICAL RESEARCH, MS, MBA
[email protected]
214 648 1836
LILIANA ROBLES
[email protected]
214 645 5354
DANIEL YANG, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Dallas, TX

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of Texas Southwestern Medical Center· Dallas, TX

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