Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc

Part of paid clinical trials in West Los Angeles, California.

Sponsor
VA Office of Research and Development
Study ID
NCT06084338
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • stereotactic ablative radiotherapy — RADIATION
    Metastasis directed
  • Pluvicto — DRUG
    PSMA targeted radiopharmaceutical therapy
  • topical testosterone — DRUG
    Topical testosterone 1.62% gel

Study Details

This trial tests if the combination of comprehensive metastasis directed therapy delivered by a precision form of external beam radiotherapy (stereotactic ablative radiotherapy), combined with PSMA targeted radiopharmaceutical therapy and cessation of castration, and then followed by testosterone replacement, is an effective treatment for metastatic castration resistant prostate cancer. All patients will be treated with stereotactic ablative radiotherapy and PSMA targeted radiopharmaceutical therapy with cessation of castration. Half of patients are randomized to either receive, or not receive, subsequent testosterone replacement.

Key Dates

Start date
Dec 14, 2023
Status verified
Dec 2025
Primary completion
Nov 29, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Metastasis directed therapy with stereotactic ablative radiotherapy to all detectable sites of disease plus PSMA radiopharmaceutical therapy and discontinuation of castration
  • Experimental: Arm 2
    Metastasis directed therapy with stereotactic ablative radiotherapy to all detectable sites of disease plus PSMA radiopharmaceutical therapy and discontinuation of castration, followed by restoration of physiologic testosterone

Primary Outcome Measure

6-month radiographic progression-free survival (rPFS) [ Time Frame: 6-months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
VA Greater Los Angeles Healthcare System, West Los Angeles, CAWest Los AngelesCalifornia90073-1003
Nicholas G Nickols, MD PhD
[email protected]
(310) 478-3711
Matthew B Rettig, MD
[email protected]
(310) 478-3711
Nicholas George Nickols, MD PhD (PRINCIPAL_INVESTIGATOR)
Edward Hines Jr. VA Hospital, Hines, ILHinesIllinois60141-3030
Abhishek Solanki, MD
[email protected]
Richard L. Roudebush VA Medical Center, Indianapolis, INIndianapolisIndiana46202-2884
Ronald Shapiro, MD
[email protected]
VA Ann Arbor Healthcare System, Ann Arbor, MIAnn ArborMichigan48105-2303
David Elliott, MD
[email protected]

Find similar trials in West Los Angeles, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
VA Greater Los Angeles Healthcare System, West Los Angeles, CA· West Los Angeles, CAEdward Hines Jr. VA Hospital, Hines, IL· Hines, ILRichard L. Roudebush VA Medical Center, Indianapolis, IN· Indianapolis, INVA Ann Arbor Healthcare System, Ann Arbor, MI· Ann Arbor, MI

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