Phase II Non-Randomized Study Evaluating POSLUMA-PSMA PET Response After Oligo- Metastatic/Progressive-directed Treatment With Radiotherapy (PROMPT-R)

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT07210086
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • ADT — DRUG
    Androgen Deprivation Therapy
  • ARSI — DRUG
    Androgen Receptor Signaling Inhibitor
  • No ADT/ARSI -decline — OTHER
    Recurrent prostate cancer with oligometastatic disease who decline ADT/ARSI and are treated with ablative intent RT alone and who have \<=5 extrapelvic lesions detected on a baseline PSMA-PET and have rising PSA.

Study Details

This study aims to evaluate the role of PSMA-PET and circulating tumor DNA (ctDNA) in monitoring prostate cancer progression and response to radiotherapy (RT). Specifically, it investigates how often early progression is detected on PSMA-PET before PSA rise, examines PET responses of lesions treated with RT at 6 and 12 months and their correlation with PSA changes and later progression, examines ctDNA changes following ablative-intent RT to metastatic sites, and explores the relationship between PSMA-PET radiological findings and ctDNA dynamics.

Key Dates

Start date
Nov 26, 2025
Status verified
Jan 2026
Primary completion
May 13, 2028
Completion
May 13, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: De novo oligometastatic disease treated with ADT+ARSI+ablative intent RT
    De novo oligometastatic disease treated with ADT+ARSI+ablative intent RT and who have \<=5 extrapelvic lesions detected on a baseline PSMA-PET and have rising PSA.
  • Other: Recurrent disease with oligometastatic disease treated with ADT+ablative intent RT
    Recurrent disease with oligometastatic disease treated with ADT+ablative intent RT and who have \<=5 extrapelvic lesions detected on a baseline PSMA-PET and have rising PSA.
  • Other: Recurrent prostate ca with oligometastatic disease who decline ADT/ARSI
    Recurrent prostate cancer with oligometastatic disease who decline ADT/ARSI and are treated with ablative intent RT alone and who have \<=5 extrapelvic lesions detected on a baseline PSMA-PET and have rising PSA.

Primary Outcome Measure

Early PD on PSMA-PET prior to PSA-progression [ Time Frame: Up to 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Rose Li, MD, PhD
[email protected]
626-359-8111

Find similar trials in Duarte, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
City of Hope Medical Center· Duarte, CA

Related Studies