Prostate CancerPhase 2RadTARGETNCT06990542
Image-guided, Tumor-focused Radiotherapy Treatment in Intermediate and High-risk Prostate Cancer
A Phase 2 study testing Image-guided tumor-focused radiation therapy in people with Prostate Cancer, run by University of California, San Diego at 1 site in United States.
Trial 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 radiotherapy with or without systemic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Image-guided tumor-focused radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2025to Dec 2033
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Diego
La Jolla, California, 92093
Genitourinary Research Team, 858-822-5354, cancerCTO@health.ucsd.edu
About this study
Official title: RAdiation Dose TAiloRing Guided by Enhanced Targeting
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.
Read the 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 the genitourinary and gastrointestinal organs, impacting their quality of life. Given the excellent survivorship after definitive prostate cancer treatment, there is interest in identifying strategies that can improve the therapeutic ratio and minimize toxicity while maintaining excellent oncologic outcomes. Intraprostatic recurrence after definitive radiation therapy occurs at the site of the primary tumor and the dose to the site of the primary tumor is an important predictor of future treatment failure. This leads to the hypothesis that, if accurate discrimination between tumor(s) and benign prostate tissue can be achieved, radiation oncologists can devise tumor-focused radiation therapy plans that deliver ablative dose radiation therapy to the tumor(s) and de-escalated dose to the remainder of the electively irradiated prostate. This strategy is now possible thanks to advanced imaging technologies that can accurately identify the primary clinically significant tumor(s) to be targeted. De-escalated dose to the remainder of the prostate may lead to low dose also to neighboring organs, such as rectum and bladder, potentially leading to lower rates of acute and late toxicity and minimizing the impact of prostate cancer treatment on quality of life. A randomized trial is required to compare the efficacy and toxicity of tumor-focused radiation therapy to that of standard radiation therapy for definitive treatment of localized prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- Image-guided tumor-focused radiation therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image-guided tumor-focused radiation therapyRadiation
Image-guided tumor-focused radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Standard of care dose radiotherapy | No intervention | Standard dose radiation therapy |
| Tumor-focused radiotherapy | Experimental | Image-guided tumor-focused radiation therapy Receives: Radiation: Image-guided tumor-focused radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute toxicity
Acute any attribution genitourinary or gastrointestinal toxicity (grade 2 or higher), compared between randomized arms, defined as the percentage of patients with Common Terminology Criteria for Adverse Events genitourinary or gastrointestinal toxicity of grade 2 or higher within 3 months of completing radiation therapy.
Based on the Common Terminology Criteria for Adverse Event, grade 1 is the lowest and grade 5 is the highest. Grade 5 represents the worst outcome (death).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start9 Jun 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Veracyte, Inc.
- Responsible party
- Principal investigator, Tyler Seibert, University of California, San Diego
- Investigators
- Tyler Seibert, MD, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990542
- Sponsor's protocol ID
- 812494
- Acronym
- RadTARGET
- Status last verified
- Feb 2026
- First submitted
- 18 May 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAdiation Dose TAiloRing Guided by Enhanced Targeting
- ClinicalTrials.gov ID
- NCT06990542
- Acronym / sponsor ID
- RadTARGET / 812494
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Veracyte, Inc.
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 the genitourinary and gastrointestinal organs, impacting their quality of life. Given the excellent survivorship after definitive prostate cancer treatment, there is interest in identifying strategies that can improve the therapeutic ratio and minimize toxicity while maintaining excellent oncologic outcomes. Intraprostatic recurrence after definitive radiation therapy occurs at the site of the primary tumor and the dose to the site of the primary tumor is an important predictor of future treatment failure. This leads to the hypothesis that, if accurate discrimination between tumor(s) and benign prostate tissue can be achieved, radiation oncologists can devise tumor-focused radiation therapy plans that deliver ablative dose radiation therapy to the tumor(s) and de-escalated dose to the remainder of the electively irradiated prostate. This strategy is now possible thanks to advanced imaging technologies that can accurately identify the primary clinically significant tumor(s) to be targeted. De-escalated dose to the remainder of the prostate may lead to low dose also to neighboring organs, such as rectum and bladder, potentially leading to lower rates of acute and late toxicity and minimizing the impact of prostate cancer treatment on quality of life. A randomized trial is required to compare the efficacy and toxicity of tumor-focused radiation therapy to that of standard radiation therapy for definitive treatment of localized prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care dose radiotherapy | No intervention | –Standard dose radiation therapy |
| Tumor-focused radiotherapy | Experimental | Radiation: Image-guided tumor-focused radiation therapyImage-guided tumor-focused radiation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Image-guided tumor-focused radiation therapyImage-guided tumor-focused radiation therapy | Radiation | Tumor-focused radiotherapy |
Primary outcome
Acute toxicity
Time frame: 3 months
Acute any attribution genitourinary or gastrointestinal toxicity (grade 2 or higher), compared between randomized arms, defined as the percentage of patients with Common Terminology Criteria for Adverse Events genitourinary or gastrointestinal toxicity of grade 2 or higher within 3 months of completing radiation therapy. Based on the Common Terminology Criteria for Adverse Event, grade 1 is the lowest and grade 5 is the highest. Grade 5 represents the worst outcome (death).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tyler Seibert, MD, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Image-guided tumor-focused radiation therapy in people with Prostate Cancer, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tyler Seibert, MD, PhD ((858) 822-5354, cancerCTO@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute toxicity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.