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 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.

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+