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Hormone Therapy

ADT with SBRT for Prostate Cancer

Phase 3

Recruiting

Led By Michael Zelefsky

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Biopsy proven unfavorable intermediate risk prostate cancer, including patients with Gleason 4+3 disease, Percent positive cores > 50% of Gleason 7 disease, or 2-3 intermediate risk factors (Gleason 7; PSA 10-20 ng/mL; or T2b-T2c)

Karnofsky Performance Scale (KPS) ≥ 80%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to year 5

Awards & highlights

Study Summary

This trial will test whether adding 6 months of hormone therapy to radiation treatment is more effective than radiation treatment alone for prostate cancer patients with a specific type of cancer. Patients will be monitored for up to

Who is the study for?

This trial is for men with a specific stage of prostate cancer called 'unfavorable intermediate risk.' They should be suitable for hormone therapy and radiation, have no prior treatments for prostate cancer, and be able to undergo biopsies. Specific details on inclusion or exclusion criteria are not provided.Check my eligibility

What is being tested?

The study compares two approaches: one group receives hormone therapy (ADT) using drugs like Leuprolide, Degarelix, or Relugolix along with targeted radiation (SBRT), while the other group gets only SBRT. Patients will be randomly assigned to these groups and monitored for up to five years.See study design

What are the potential side effects?

Possible side effects include those from ADT such as hot flashes, fatigue, sexual dysfunction, bone thinning; and from SBRT like urinary issues or rectal discomfort. The exact side effects depend on individual patient responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is intermediate risk with specific Gleason scores or PSA levels.

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I can carry out normal activities with minimal symptoms.

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My prostate is smaller than 90 cc according to my MRI or CT scan.

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My kidney function is normal, with creatinine levels within the limit.

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My blood counts meet the required levels for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to year 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to year 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to year 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disease-Free Survival

Secondary outcome measures

Change in 12-Item Short Form Health Survey (SF-12) Score

Change in Expanded Prostate Cancer Index Composite (EPIC) Questionnaire Score

Change in International Prostatism Symptom Score (IPSS)

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ADT with SBRTExperimental Treatment2 Interventions

The ADT patients will be treated with monthly Degarelix, or Leuprolide injections or daily Relugolix pills. After three months have elapsed, these patients as per routine will undergo SBRT. SBRT comprises stereotactic, ultra-fractionated radiotherapy every other day for five total treatments.

Group II: SBRT AloneActive Control1 Intervention

Participants treated with SBRT alone (standard of care) will be administered stereotactic, ultra-fractionated radiotherapy every other day for five total treatments.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,372 Previous Clinical Trials

840,718 Total Patients Enrolled

25 Trials studying Prostate Cancer

5,270 Patients Enrolled for Prostate Cancer

Michael ZelefskyPrincipal InvestigatorNYU Langone Health

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are prospective participants able to enroll in this research study at the present time?

"Indeed, the details on clinicaltrials.gov confirm that recruitment is ongoing for this research study. Originally listed on April 16th, 2024, and most recently updated on May 2nd, 2024, the trial aims to enroll 392 participants at a single site."

Answered by AI

What are the risks associated with using ADT in conjunction with SBRT for individuals undergoing treatment?

"The safety assessment of ADT with SBRT by our team at Power was rated as 3, considering the trial's Phase 3 status with existing efficacy data and numerous rounds of safety data."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer

2024. "ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06397703.

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