What side effects are associated with this type of intervention?

Common treatments for prostate cancer, including SBRT, can have various side effects. SBRT, which delivers highly focused radiation doses, aims to minimize damage to surrounding healthy tissue but can still cause urinary and bowel issues, fatigue, and erectile dysfunction. Traditional radiation therapy and surgery may also lead to similar side effects, with surgery additionally posing risks of incontinence and infection. Androgen deprivation therapy (ADT), often used in advanced cases, can result in hot flashes, decreased libido, osteoporosis, and metabolic changes. Patients should discuss these potential side effects with their healthcare provider to make informed treatment decisions.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including various forms of radiation therapy. Stereotactic Body Radiation Therapy (SBRT) is a newer, highly precise form of radiation therapy that targets tumors with minimal damage to surrounding tissues. While SBRT itself is being studied for its efficacy in prostate cancer, other FDA-approved treatments include external beam radiation therapy (EBRT) and brachytherapy. Additionally, androgen deprivation therapy (ADT) and newer hormonal agents like enzalutamide and abiraterone have been approved for advanced stages of the disease. These treatments aim to manage and control prostate cancer, improving patient outcomes and quality of life.

What other types of research exist?

Promising novel alternatives to SBRT for prostate cancer patients include focal therapies such as thermal ablation (using heat), cryotherapy (using cold), High-Intensity Focused Ultrasound (HIFU), laser ablation (FLA), and irreversible electroporation (IRE). These methods aim to target the tumor precisely while minimizing damage to surrounding healthy tissue. Additionally, systemic treatments like androgen deprivation therapy (ADT) combined with newer agents such as abiraterone, enzalutamide, or apalutamide, and advanced imaging techniques for better targeting, are also promising options.

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Radiation

SBRT for Prostate Cancer

Phase 2

Recruiting

Led By Krishnan R Patel, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will test a new type of radiation (SBRT) to treat prostate cancer with fewer side effects than standard treatments. Participants will have scans and blood tests, receive radiation in two sessions, then be followed-up for two years.

Who is the study for?

This trial is for men aged 18+ with untreated localized prostate cancer that hasn't spread outside the gland. They must be able to consent, have a performance status indicating they can carry out daily activities, and agree to use effective contraception during and up to 120 days post-treatment. Exclusions include those planning other treatments like ADT or chemotherapy, with high-risk prostate cancer features, prior curative treatment for prostate cancer, certain infections unless treated and cured, or conditions preventing MRI scans.Check my eligibility

What is being tested?

The trial tests focal therapy using SBRT on patients with a single tumor in the prostate. It aims to see if this targeted radiation approach leads to fewer side effects than whole-gland surgery or radiation. Participants will undergo two sessions of SBRT about one week apart without sedation and follow-up for two years including scans (MRI & PSMA PET/CT) and blood tests.See study design

What are the potential side effects?

Potential side effects from SBRT may include urinary issues due to inflammation near the treated area, fatigue from radiation exposure, skin reactions at the site of treatment such as redness or soreness, bowel changes like diarrhea if nearby intestines are affected by radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Pathologic complete response rate

Secondary outcome measures

Absolute and relative fraction of free PSA to bound PSA

Longitudinal quality of life (QoL)

Nadir PSA

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1/Focal SBRTExperimental Treatment2 Interventions

Focal SBRT to the tumor focus within the prostate, with response assessed by biopsy and imaging, including 18F-DCFPyL PET/CT.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~780

18F-DCFPyL

2019

Completed Phase 3

~350

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for prostate cancer include surgery, traditional radiation therapy, and SBRT. Surgery involves removing the prostate gland to eliminate cancerous tissue but can lead to significant side effects. Traditional radiation therapy uses high-energy rays to kill cancer cells but often affects surrounding healthy tissue, causing side effects. SBRT, a newer form of radiation therapy, delivers highly focused radiation doses directly to the tumor, minimizing damage to surrounding healthy tissue. This precision reduces side effects and improves the quality of life for patients. Understanding these mechanisms helps prostate cancer patients make informed decisions about their treatment options, balancing effectiveness and potential side effects.

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Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,721 Previous Clinical Trials

40,965,088 Total Patients Enrolled

565 Trials studying Prostate Cancer

529,162 Patients Enrolled for Prostate Cancer

Krishnan R Patel, M.D.Principal InvestigatorNational Cancer Institute (NCI)

Media Library

Stereotactic Body Radiation Therapy (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05616650 — Phase 2

~28 spots leftby Dec 2027

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