Image-guided Radiotherapy for Prostate Cancer

(RAD-TARGET Trial)

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University of California, San Diego

Disqualifiers: Bilateral hip implants, prior prostatectomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of radiation therapy for prostate cancer that targets the tumor more precisely. Researchers aim to determine if this focused treatment reduces side effects on nearby organs compared to standard whole-prostate radiation. They will assess side effects, survival rates, and quality of life. Men with prostate cancer planning to undergo radiation therapy, who have visible lesions on specific scans, might be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in cancer care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this image-guided tumor-focused radiotherapy is safe for prostate cancer patients?

Studies have shown that image-guided radiotherapy for prostate cancer is generally well-tolerated by patients. Research indicates that survival rates for patients receiving this therapy are similar to those undergoing standard treatments, suggesting comparable safety.

Radiation therapy for prostate cancer can sometimes cause side effects like tiredness or skin irritation. Image-guided therapy aims to reduce these effects by precisely targeting the tumor and minimizing radiation exposure to nearby organs. This approach may lead to fewer issues with organs close to the prostate, such as the bladder and intestines.

Currently, an early-phase trial is testing this treatment to assess its safety for patients. While no major safety concerns have been reported so far, this phase of the study will provide more detailed information on any possible side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Researchers are excited about image-guided tumor-focused radiation therapy for prostate cancer because it offers a more precise approach than traditional radiation methods. Unlike standard radiation therapy, which targets a broader area, this technique directly focuses on the tumor, potentially reducing damage to surrounding healthy tissues. This targeted method may lead to fewer side effects and improved outcomes, making it a promising advancement in prostate cancer treatment.

What evidence suggests that image-guided tumor-focused radiotherapy is effective for prostate cancer?

This trial will compare standard dose radiotherapy with image-guided, tumor-focused radiation therapy for prostate cancer. Studies have shown that image-guided, tumor-focused radiation therapy can effectively treat prostate cancer. In one study, patients who received this treatment experienced fewer bowel problems and improved quality of life compared to those who underwent standard radiation therapy targeting the whole prostate. This method may also reduce the radiation dose to nearby organs, potentially resulting in fewer side effects. Research suggests that real-time imaging helps target the treatment more precisely at the cancer, potentially leading to better patient outcomes. ^{4 6 7 8 9}

Who Is on the Research Team?

Tyler Seibert, MD, PhD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for men over 18 with intermediate or high-risk prostate cancer, who have a visible lesion on MRI or PSMA PET-CT and plan to undergo curative-intent radiation therapy. They must consent to the study's procedures and be available throughout its duration. Men able to cause pregnancy must use effective contraception during treatment and for six months after.

Inclusion Criteria

I will use effective birth control during and for 6 months after radiation therapy.

I have signed and dated the consent form.

I am at least 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive image-guided, tumor-focused radiotherapy or standard dose radiotherapy

6-8 weeks

Follow-up

Participants are monitored for acute genitourinary and gastrointestinal toxicity

3 months

Long-term follow-up

Participants are monitored for late toxicity, overall survival, metastasis-free survival, and quality of life

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Image-guided Tumor-focused Radiation Therapy

Trial Overview The trial tests image-guided, tumor-focused radiotherapy versus standard whole-prostate treatment in patients with prostate cancer. It aims to see if focusing the radiation reduces damage to nearby organs, lessens side effects, and impacts survival rates, metastasis-free survival, and quality of life.

How Is the Trial Designed?

Group I: Tumor-focused radiotherapy Experimental Treatment 1 Intervention

Image-guided tumor-focused radiation therapy

Group II: Standard of care dose radiotherapy Active Control 1 Intervention

Standard dose radiation therapy

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10348338/

Image-guided radiation therapy (IGRT) in prostate cancer ... Responses of 541 patients were evaluated, 85% belonged to the intermediate-high risk group, 65% received adjuvant or salvage radiotherapy (RT), 80% received ...

2. cancer.gov cancer.gov/clinicaltrials/NCI-2025-04471

Image Guided Tumor Focused Radiation Therapy ... This clinical trial compares the effect of image guided tumor focused radiation therapy to standard whole prostate radiation therapy in treating patients

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301620309378

Real-Time Image Guided Ablative Prostate Cancer ... Patients with prostate cancer treated with real-time IGRT showed significantly lower bowel morbidity and improved health-related quality of life compared with a ...

4. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.921465/full

Long-term outcomes of prostate intensity-modulated ... The 10-year rates of overall survival, distant control, biochemical control, and local control were 66%, 88%, 77%, and 99%, respectively ( ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11952913/

Long-Term Clinical Outcomes of Radical Prostatectomy ... The 15-year overall survival (OS) rates were 80.9% for RP and 58.3% for IMRTG; however, this difference was not significant in the multivariate analysis, likely ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8506193/

Safety of image-guided radiotherapy in definitive ... We demonstrated that the overall survival for prostate cancer patients with IGRT was not worse than those who did not undergo IGRT.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04035642

Phase II Study of Single-Dose Image-Guided Radiotherapy ... The present study evaluates clinical outcomes and treatment-related toxicity following definitive ultra-high single dose external beam radiotherapy.

8. cancer.org cancer.org/cancer/types/prostate-cancer/treating/radiation-therapy.html

Side Effects of Radiation Therapy for Prostate Cancer This type of radiation can be used to try to cure earlier-stage cancers, to treat cancers that have grown outside the prostate, or to help relieve symptoms ...

9. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-025-02713-9

PRO-FAST single-fraction ablative, urethral-sparing, HDR-like ... Radiotherapy (RT) is a standard curative treatment for prostate cancer (PCa) and there is growing evidence of the high efficacy of moderate ...