SBRT + ADT for Prostate Cancer

Overseen By Michael Zelefsky, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Androgen deprivation, Anti-androgens

Disqualifiers: Prostate brachytherapy, Crohn's, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 months

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for treating prostate cancer that has returned after initial treatment. It employs advanced imaging to guide precise radiation therapy, known as Stereotactic Body Radiation Therapy (SBRT), combined with hormone therapy, to reduce serious side effects, particularly those affecting urination. The trial aims to determine if this method is safe and effective for men whose prostate cancer has recurred after external beam radiation. Suitable candidates are men diagnosed again with prostate cancer within the prostate and not currently undergoing hormone therapy. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future prostate cancer treatments.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot be actively undergoing androgen deprivation therapy or taking anti-androgens at the time of enrollment.

What prior data suggests that this MR-guided SBRT is safe for prostate cancer treatment?

Research has shown that stereotactic body radiation therapy (SBRT) is generally safe for treating prostate cancer. One study found that patients who received SBRT had good disease control and manageable side effects. However, about 27% of men in the SBRT group reported urinary problems over five years, compared to 18% of those who had standard radiation therapy.

Another study found that patients treated with SBRT experienced fewer issues with bowel, urinary, and sexual functions compared to other treatments. This suggests SBRT might be gentler on the body in these areas. Overall, SBRT appears both effective and tolerable for prostate cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of MRI-Linac-based SBRT with online adaptive replanning for prostate cancer because it combines precise imaging with targeted radiation therapy. Unlike traditional radiation therapy, which can affect surrounding healthy tissues, this method uses real-time MRI guidance to adapt the radiation dose, focusing specifically on the prostate. This precision reduces potential side effects and enhances the effectiveness of the treatment. Additionally, when combined with androgen deprivation therapy (ADT), this approach could potentially improve treatment outcomes and reduce treatment duration compared to standard options.

What evidence suggests that this trial's treatment could be effective for prostate cancer?

Studies have shown that Stereotactic Body Radiation Therapy (SBRT) effectively treats certain prostate cancers. Research indicates that SBRT provides good long-term disease control, with 83.6% of patients not experiencing cancer worsening within five years after treatment. It also relieves symptoms without causing severe side effects. However, some patients may experience urinary problems within the first two years after treatment. The overall safety and effectiveness of SBRT make it a promising option for those with recurrent prostate cancer. Participants in this trial will receive MRI-Linac-based SBRT with online adaptive replanning, combined with 4-6 months of androgen deprivation therapy (ADT). ^{1 2 3 5 6}

Who Is on the Research Team?

Michael Zelefsky, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for men with biopsy-proven prostate cancer that has come back after previous external beam radiotherapy. Participants should be informed about their condition using PSMA/PET scans and are willing to undergo MR-guided SBRT as a salvage treatment.

Inclusion Criteria

I am a man aged 18 or older.

International Prostatism Symptom Score (IPSS) ≤ 20

Patient must be available for follow-up. After 2 years of follow-up, upon completion of post-treatment biopsy, telephone, and chart review-based follow-up will be acceptable for up to 5 years

Exclusion Criteria

I haven't had any cancer except for certain skin cancers or any in remission for 3+ years in the last 2 years.

MRI ineligibility due to the presence of a cardiac pacemaker, defibrillator, or other implanted metallic or electronic device which is considered MR unsafe, severe claustrophobia, inability to lie flat for the duration of the study, etc.

I have Crohn's disease or ulcerative colitis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MR-guided stereotactic body radiation therapy (SBRT) with online adaptive replanning, along with 4-6 months of androgen deprivation therapy (ADT)

4-6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on urinary toxicity outcomes and other health-related quality of life measures

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Body Radiation Therapy (SBRT)

Trial Overview The study tests the safety and effectiveness of MR-Linac-guided SBRT combined with ADT in treating recurrent prostate cancer. It aims to see if this approach reduces serious toxicity while monitoring urinary side effects over two years.

How Is the Trial Designed?

Group I: MRI-Linac-based SBRT with online adaptive replanning Experimental Treatment 2 Interventions

Participants will be treated with MR-guided stereotactic body radiation therapy/radiosurgery (SBRT) directed to the prostate using a 1.5 Tesla (1.5T) Elekta UNITY MR-Linac system in conjunction with 4-6 months of androgen deprivation therapy (ADT).

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8557180/

Five-year outcomes of stereotactic body radiation therapy ... Overall, SBRT may offer a higher 5-year bPFS rate of 83.6% and effective symptom relief without severe adverse effects. Additionally, no grade 4 or above ...

2. cancer.gov cancer.gov/news-events/cancer-currents-blog/2024/prostate-cancer-sbrt-effective-safe

SBRT Proves Effective for Some Prostate Cancers - NCI Trial participants who were randomly assigned to receive SBRT had a higher risk of developing some urinary problems over the first 2 years after ...

3. astro.org astro.org/news-and-publications/news-and-media-center/news-releases/2025/shorter-radiation-improves-patient-experience-but-not-disease-control-for-intermediate-risk-prostate

Shorter radiation improves patient experience but not ... Patients treated with stereotactic body radiation therapy (SBRT) reported fewer declines in bowel, urinary and sexual functioning but were more ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.4_suppl.323

Long-term treatment outcomes from the International Multi ... Conclusions: The safety and efficacy profile of SBRT for high-risk prostate cancer remains favorable at long-term follow-up. ADT of medium ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2773160X25000078

The effectiveness and safety of stereotactic body ... The results show minor, non-significant differences in survival rates compared to conventional fractionation, a type of external radiation, after two and five ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.129

Safety evaluation of stereotactic body radiation therapy ... Ultimately, 84% of patients completed all 6 cycles of 177Lu-PSMA-617 (range 4-6). The median follow-up time was 19.1 months (IQR 15.5-22.4) ...