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Prostate CancerEarly Phase 1NCT05477823

Imaging and Genomic Biomarkers to Predict Response in Prostate Cancer

A Early Phase 1 study testing External beam radiation therapy, Prostate brachytherapy boost and Androgen deprivation therapy in people with Prostate Cancer, run by University of Wisconsin, Madison at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to evaluate the imaging and gene expression biomarkers in prostate cancer. Participants have high-risk prostate cancer and have indicated they will undergo external beam radiation therapy, brachytherapy, and androgen deprivation therapy (EBRT+BTX+ADT). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Prostate Cancer
What is being tested?
External beam radiation therapy, Prostate brachytherapy boost and Androgen deprivation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
8 Mar 2023to Aug 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18
  • Histologically confirmed adenocarcinoma of the prostate
  • Cancer classified as high-risk or very high-risk by National Comprehensive Cancer Network (NCCN) criteria: Grade group ≥4, PSA >20, or primary tumor stage ≥T3a
  • ECOG performance status 0-1
  • Agreed to undergo EBRT, high dose rate (HDR) brachytherapy boost, and 6-36 months of ADT as part of standard of care therapy prior to study enrollment
  • Able to undergo a HDR brachytherapy implant: Pre-radiation IPSS score ≤20 with or without medical management; prostate ≤60 cc as measured by MRI or ultrasound; no prior trans-urethral resection of prostate (TURP); and, median lobe extending into the bladder <1 cm
  • No prior or concurrent malignancy unless disease-free for at least 5 years

Who cannot join

  • Evidence of regional or distant metastatic disease on pre-treatment bone scan, pelvic MRI, and/or CT of the abdomen/pelvis
  • Prior pelvic radiation therapy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Wisconsin

    Madison, Wisconsin, 53705

Other trials in United States

About this study

Official title: Pilot Study to Identify Radiogenomic Biomarkers to Predict Early Treatment Response to Androgen Deprivation Therapy and Radiation Therapy in High Risk Prostate Cancer

The purpose of this study is to evaluate the imaging and gene expression biomarkers in prostate cancer. Participants have high-risk prostate cancer and have indicated they will undergo external beam radiation therapy, brachytherapy, and androgen deprivation therapy (EBRT+BTX+ADT). Participants can expect to be in this study for up to 5 years.

Read the detailed description

This is a pilot study to prospectively investigate potential predictive imaging and genomic biomarkers for patients with high-risk prostate cancer treated with standard of care EBRT + BTX + ADT. The primary imaging modalities that will be evaluated will be PSMA positron emission tomography (PET) and multi-parametric magnetic resonance imaging (MRI). Pre-treatment PET/MRI scans will also be obtained as part of standard of care prior to study enrollment. Response will be assessed on a mid-treatment PET/MRI scan obtained for research purposes after completion of EBRT but prior to brachytherapy boost. PET/CT (computerized tomography) may be used instead if PET/MRI is not technically possible. Imaging response will be compared to pathology from image-directed prostate biopsies taken at the time of the brachytherapy boost. The primary genomic marker that will be evaluated is a clinically available gene-expression array, Decipher, that will be obtained as part of standard of care prior to study enrollment.

Conditions
Prostate Cancer
Being tested
External beam radiation therapy, Prostate brachytherapy boost, Androgen deprivation therapy, Positron emission tomography (PET)/magnetic resonance imaging (MRI)
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • External beam radiation therapyRadiation

    Standard of care EBRT

  • Prostate brachytherapy boostRadiation

    Standard of care BTX

  • Androgen deprivation therapyDrug

    Standard of care ADT

  • Positron emission tomography (PET)/magnetic resonance imaging (MRI)Diagnostic test

    Pelvic PET scanning with tracer will take approximately 45 minutes. This will be followed by the injection of a contrast agent followed by whole body PET/MRI scanning which will take approximately 30 minutes.

Study groups in NCT05477823
Study groupRoleWhat they receive
EBRT + BTX + ADT, PET and MRIExperimentalStandard of care EBRT + BTX + ADT, with mid-treatment PET and MRI (or PET and CT) scans for research.
Receives: Radiation: External beam radiation therapy; Radiation: Prostate brachytherapy boost; Drug: Androgen deprivation therapy; Diagnostic Test: Positron emission tomography (PET)/magnetic resonance imaging (MRI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Imaging markers for mid-treatment response

    Evaluate prostate specific membrane antigen (PSMA) PET/MRI for imaging biomarkers that predict mid-treatment response to ADT and EBRT to identify participants at risk for poor response to radiation therapy and ADT.

    Measured: Mid-treatment (approximately 3 months into treatment)

Secondary outcomes (5)

  1. Genomic signatures correlated with imaging response

    Determine if the Decipher and PORTOS genomic scores (high vs low) and basal/luminal genomic subtypes are correlated with change in PSMA standardized uptake value (SUV) pre-to-mid-treatment.

    Measured: Baseline and mid-treatment (approximately 3 months into treatment)

  2. Establish a correlation between PET imaging response and pathologic response

    PET images will be assessed for response using change in SUV in order to establish a correlation between imaging response and pathologic response to ADT and EBRT on a lesion-by-lesion basis. Pathologic response will be evaluated considering change in percent core involvement, prostate cancer epithelial/stromal (E/S) ratio, PSMA, CC3 and Ki67 expression. Concordance will be assessed using the Kappa statistic.

    Measured: Baseline and mid-treatment (approximately 3 months into treatment)

  3. Establish a correlation between MRI imaging response and pathologic response

    MR images will be assessed for response using change in apparent diffusion coefficient (ADC) in order to establish a correlation between imaging response and pathologic response to ADT and EBRT on a lesion-by-lesion basis. Pathologic response will be evaluated as described in Outcome 3. Concordance will be assessed using the Kappa statistic.

    Measured: Baseline and mid-treatment (approximately 3 months into treatment)

  4. Imaging and genomic markers for prostate specific antigen (PSA) recurrence.

    Determine if imaging and genomic markers that predict for mid-treatment pathologic response also predict PSA recurrence.

    Measured: Baseline, 3 months post therapy, every 6 months for 5 years

  5. Evaluate blood-based biomarkers for treatment response.

    Messenger RNA from circulating tumor cells (CTCs) will be extracted to determine if presence of androgen receptor variants and a neuroendocrine prostate cancer signature (a score based upon the expression of a set of genes) is correlated with pathologic response (determined as outlined in Outcome 3).

    Measured: Baseline and mid-treatment (approximately 3 months into treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2022
  2. Study start8 Mar 2023
  3. Primary completion2 Apr 2026
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05477823
Sponsor's protocol ID
2022-0493
Other IDs
2022-0493, Protocol version 9/5/2025, A533300, SMPH/HUMAN ONCOLOGY/HUMAN ONCO, UW20099
Status last verified
May 2026
First submitted
21 Jul 2022
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing External beam radiation therapy, Prostate brachytherapy boost and Androgen deprivation therapy in people with Prostate Cancer, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Imaging markers for mid-treatment response (time frame: Mid-treatment (approximately 3 months into treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05477823.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

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