Image-guided, Tumor-focused Radiotherapy Treatment in Intermediate and High-risk Prostate Cancer

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT06990542
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Image-guided tumor-focused radiation therapy — RADIATION
    Image-guided tumor-focused radiation therapy

Study Details

This is a phase II non-blinded randomized controlled trial of image-guided, tumor-focused radiotherapy in patients with intermediate- or high-risk prostate cancer planning to undergo definitive radiotherapy with or without systemic therapy. The image-guided, tumor-focused radiotherapy will be compared to standard, whole-prostate treatment. The investigators hypothesize that tumor-focused radiotherapy reduces the radiation dose to organs close to the prostate, possibly leading to decreased acute toxicity to the genitourinary and gastrointestinal organs. The investigators will measure acute and late genitourinary and gastrointestinal toxicity due to radiation and regardless of cause. The investigators will also measure overall survival, metastasis-free survival, and quality of life, as well as biomarkers that may help predict, in the future, who may have a worse toxicity following radiation therapy.

Key Dates

Start date
Jun 9, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2033

Study Design

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

Arms

  • No Intervention: Standard of care dose radiotherapy
    Standard dose radiation therapy
  • Experimental: Tumor-focused radiotherapy
    Image-guided tumor-focused radiation therapy

Primary Outcome Measure

Acute toxicity [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San DiegoLa JollaCalifornia92093
Genitourinary Research Team
[email protected]
858-822-5354

Find similar trials in La Jolla, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of California, San Diego· La Jolla, CA

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