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NCT05050084RECRUITINGIRB Ready

Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial

Sponsored by NRG Oncology

Quick Self-Assessment

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Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

This phase III trial uses the Decipher risk score to guide therapy selection. Decipher score is based on the activity of 22 genes in prostate tumor and may predict how likely it is for recurrent prostate cancer to spread (metastasize) to other parts of the body. Decipher score in this study is used for patient selection and the two variations of treatment to be studied: intensification for higher Decipher score or de-intensification for low Decipher score.

Who Can Participate

Inclusion Criteria

Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of the prostate within 270 days prior to registration
Unfavorable intermediate risk prostate cancer, defined as having ALL the following bulleted criteria:
Has at least one intermediate risk factor (IRF):
PSA 10-20 ng/mL
Clinical stage T2b-c (digital rectal examination \[DRE\] and/or imaging) by American Joint Committee on Cancer (AJCC) 8th edition
Gleason score 7 (Gleason 3+4 or 4+3 \[ International Society of Urological Pathology (ISUP) Grade Group 2-3\])
Has ONE or more of the following 'unfavorable' intermediate-risk designators:
\> 1 immature reticulocyte fraction (IRF)
Gleason 4+3=7 (ISUP Grade Group 3)
\>= 50% of biopsy cores positive
Biopsies may include 'sextant' sampling of right/left regions of the prostate, often labeled base, mid-gland and apex. All such 'sextant' biopsy cores should be counted. Men may also un

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

2050 participants

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Gender

MALE

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Sponsor

NRG Oncology

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Birmingham

Alabama

Location available
View Birmingham location page
RECRUITING

Gilbert

Arizona

Location available
View Gilbert location page
RECRUITING

Gilbert

Arizona

Location available
View Gilbert location page
RECRUITING

Peoria

Arizona

Location available
View Peoria location page
RECRUITING

Phoenix

Arizona

Location available
View Phoenix location page
RECRUITING

Scottsdale

Arizona

Location available
View Scottsdale location page
RECRUITING

Surprise

Arizona

Location available
View Surprise location page
RECRUITING

Little Rock

Arkansas

Location available
View Little Rock location page
RECRUITING

Auburn

California

Location available
View Auburn location page

๐Ÿ“ And 557 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Prostate Cancer Treatment in Birmingham?

Join others in Alabama exploring innovative treatment options through clinical research

Prostate Cancer Treatment Options in Birmingham, Alabama

If you're searching for Prostate Cancer treatment in Birmingham, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Birmingham, Gilbert, Gilbert and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Prostate Cancer. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 2050 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Prostate Cancer?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Prostate Cancer

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Prostate Cancer Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05050084. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.