NCT06990542RecruitingPhase 2
Image-guided, Tumor-focused Radiotherapy Treatment in Intermediate and High-risk Prostate Cancer
RAdiation Dose TAiloRing Guided by Enhanced Targeting
Source: ClinicalTrials.gov · Last updated 17 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 18 May 2025
- Start date
- 9 Jun 2025
- Primary completion date
- Dec 2028
- Lead sponsor
- University of California, San Diego
- Diseases
- Prostate cancer
- NCT number
- NCT06990542
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 150
- From 9 Jun 2025 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California San Diego Coordinator of this site? Confirm its status | La Jolla | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.