Status:
RECRUITING
Image-guided, Tumor-focused Radiotherapy Treatment in Intermediate and High-risk Prostate Cancer
Lead Sponsor:
University of California, San Diego
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
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 radiot...
Detailed Description
Definitive radiation therapy for prostate cancer with dose intensification and/or focal boosting has excellent oncologic outcomes. However, many patients experience long-term toxicity in particular to...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- At least 18 years old
- Histologic confirmation of prostate adenocarcinoma with plan for curative-intent radiation therapy
- Lesion visible on prostate Magnetic Resonance Imaging and/or Prostate-Specific Membrane Antigen Positron Emission Tomography-Computed Tomography (according to the treating physician) with concordant pathology from biopsy needle locations.
- For participants able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner during the radiation therapy treatment and for at least 6 months afterward.
Exclusion
- Bilateral hip implants
- Prior prostatectomy
- Prior prostate cancer treatment (for example, focal therapy). Note that participants who started hormone therapy within the 90 days prior to randomization are eligible, as long as study-compatible imaging was performed within the 4 months prior to starting the hormone therapy.
- Prior radiation therapy to an area requiring treatment in the present study
Key Trial Info
Start Date :
June 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2033
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06990542
Start Date
June 9 2025
End Date
December 1 2033
Last Update
June 29 2025
Active Locations (1)
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1
University of California, San Diego
La Jolla, California, United States, 92093