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Stage IIC Prostate Cancer AJCC v8Phase 2NCT06129851

Relugolix in Combination With Radiation Therapy for Treating Patients With High Risk Prostate Cancer

A Phase 2 study testing Biospecimen Collection, Bone Scan and Brachytherapy in people with Stage IIC Prostate Cancer AJCC v8 and Stage III Prostate Cancer AJCC v8, run by University of Kansas Medical Center at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This phase II trial evaluates the best duration for relugolix to be given in combination with radiation therapy when treating patients with high risk prostate cancer. Prostate cancer is a hormonal influenced cancer. Part of the usual treatment for patients with prostate cancer is androgen deprivation therapy (ADT). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Biospecimen Collection, Bone Scan and Brachytherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteUnited States
Study dates
20 Nov 2023to 23 Oct 2026
Phase
Phase 2
Are there results?
None posted in the registry

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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability of participant or Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
  • Life expectancy > 5 years
  • Patient diagnosed with National Comprehensive Cancer Network (NCCN) high risk and very high risk prostate cancer.
  • High risk is defined as:
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  • T3a or
  • Grade group 4 or 5 or
  • Prostate-specific antigen (PSA) > 20 ng/mL
  • Very high risk is defined as:
  • T3b to T4 or
  • Primary Gleason pattern 5 or
  • Two or three high-risk features or
  • > 4 cores with grade group 4 or 5
  • Eligible for treatment with combination brachytherapy, external beam radiation, and ADT
  • Leukocytes >= 1.0 K/UL
  • Platelets >= 100 K/UL
  • Hemoglobin ≥ 9 g/dL
  • Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal (ULN)
  • Men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed for the duration of study participation and for 2 weeks following completion of relugolix therapy

Who cannot join

  • Simultaneously enrolled in any therapeutic clinical trial
  • Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study
  • Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
  • Has a known allergic reaction to any excipient or component contained in the study drug formulation
  • Active grade 3 (per the National Cancer Institute [NCI] CTCAE, version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment
  • Current androgen deprivation therapy (unless testosterone > 50 ng/dL). Please note prior or concurrent bicalutamide at 50 mg/daily or less is allowed. Prior androgen deprivation therapy is allowed if testosterone has recovered to > 50 ng/dL
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  • Prolonged echocardiogram corrected QT (QTc) interval > 440 ns
  • Prior pelvic therapy that would significantly overlap with radiation treatment fields
  • Prior prostatectomy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

    Xinglei Shen, 913-588-3600, xshen@kumc.edu

    Xinglei Shen

Other trials in United States

About this study

Official title: Quantifying Optimal Relugolix Duration With Radiation in High Risk Prostate Cancer (QURE-PC)

This phase II trial evaluates the best duration for relugolix to be given in combination with radiation therapy when treating patients with high risk prostate cancer. Prostate cancer is a hormonal influenced cancer. Part of the usual treatment for patients with prostate cancer is androgen deprivation therapy (ADT). ADT is used to lower the amount of testosterone in the body, because testosterone appears to help prostate cancer grow. Relugolix works to reduce testosterone levels, which may inhibit proliferation of prostate cancer cells. It is approved by the Food and Drug Administration to treat prostate cancer. Adding relugolix to standard radiation therapy might work better and have fewer side effects than prior forms of hormonal therapy, but the optimal duration of relugolix in combination with radiation is not known.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To compare the biochemical recurrence rate between 12 and 24 months of relugolix in patients with high risk prostate cancer treated with combination external beam radiation and brachytherapy.

SECONDARY OBJECTIVES:

  1. To compare the composite quality of life in patient treated with 12 months and 24 months of relugolix as assessed by the Expanded Prostate Composite Index Short Form (EPIC-26) instrument.

II. To compare the treatment related toxicity between 12 months and 24 months of relugolix as assessed by Common Terminology Criteria for Adverse Events version 5.0. (CTCAE v 5.0) criteria.

III. To compare the rate of major adverse cardiovascular events (MACE) in patients treated with 12 and 24 months of relugolix.

IV. To establish the rate of patient compliance using patient reported drug diary.

  1. To compare the rate of testosterone recovery after 12 and 24 months of relugolix.

EXPLORATORY OBJECTIVE:

  1. To establish Decipher genomic classifier as predictor of cancer control.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive relugolix orally (PO) once daily (QD). Cycles repeat every 3 months for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 30 to 180 days after start of relugolix, patients undergo brachytherapy and external beam radiation over 25 fractions. Patients undergo bone scan, computed tomography (CT) or magnetic resonance imaging (MRI) or prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scan during screening. Patients also undergo dual x-ray absorptiometry (DEXA) scan and may optionally undergo blood sample collection throughout the trial.

ARM B: Patients receive relugolix PO QD. Cycles repeat every 3 months for 24 months in the absence of disease progression or unacceptable toxicity. Beginning 30 to 180 days after start of relugolix, patients undergo brachytherapy and external beam radiation over 25 fractions. Patients undergo bone scan, CT or MRI or PSMA PET scan during screening. Patients also undergo DEXA scan and may optionally undergo blood sample collection throughout the trial.

After completion of study treatment, patients in Arm A are followed up every 3 months for 12 months and then every 6 months for up to 36 months and patients in Arm B are followed up every 6 months for up 36 months.

Being tested
Biospecimen Collection, Bone Scan, Brachytherapy, Computed Tomography, Dual X-ray Absorptiometry
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Bone ScanProcedure or surgery

    Also called Bone Scintigraphy

    Undergo bone scan

  • BrachytherapyRadiation

    Also called Brachytherapy, NOS, Internal Radiation, Internal Radiation Brachytherapy, Internal Radiation Therapy

    Undergo brachytherapy

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Dual X-ray AbsorptiometryProcedure or surgery

    Also called BMD scan, bone mineral density scan, DEXA, DEXA (Bone Density)

    Undergo DEXA scan

  • External Beam Radiation TherapyRadiation

    Also called Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy

    Undergo external beam radiation therapy

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance

    Undergo MRI

  • PSMA PET ScanProcedure or surgery

    Also called Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomography

    Undergo PSMA PET

  • Questionnaire AdministrationOther

    Ancillary studies

  • RelugolixDrug

    Also called N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, Relumina, TAK 385

    Given PO

Study groups in NCT06129851
Study groupRoleWhat they receive
Arm A (relugolix, brachytherapy, external beam radiation)ExperimentalPatients receive relugolix PO QD. Cycles repeat every 3 months for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 30 to 180 days after start of relugolix, patients undergo brachytherapy and external beam radiation over 25 fractions. Patients undergo bone scan, CT or MRI or PSMA PET scan during screening. Patients also undergo DEXA scan and may optionally undergo blood sample collection throughout the trial.
Receives: Procedure: Biospecimen Collection; Procedure: Bone Scan; Radiation: Brachytherapy; Procedure: Computed Tomography; Procedure: Dual X-ray Absorptiometry; Radiation: External Beam Radiation Therapy; Procedure: Magnetic Resonance Imaging; Procedure: PSMA PET Scan; Other: Questionnaire Administration; Drug: Relugolix
Arm B (relugolix, brachytherapy, external beam radiation)ExperimentalPatients receive relugolix PO QD. Cycles repeat every 3 months for 24 months in the absence of disease progression or unacceptable toxicity. Beginning 30 to 180 days after start of relugolix, patients undergo brachytherapy and external beam radiation over 25 fractions. Patients undergo bone scan, CT or MRI or PSMA PET scan during screening. Patients also undergo DEXA scan and may optionally undergo blood sample collection throughout the trial.
Receives: Procedure: Biospecimen Collection; Procedure: Bone Scan; Radiation: Brachytherapy; Procedure: Computed Tomography; Procedure: Dual X-ray Absorptiometry; Radiation: External Beam Radiation Therapy; Procedure: Magnetic Resonance Imaging; Procedure: PSMA PET Scan; Other: Questionnaire Administration; Drug: Relugolix

What is being measured

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

  1. Biochemical recurrence

    Will be defined as serum prostate-specific antigen (PSA) level of nadir + 2 ng/mL by blood test.

    Measured: Up to 3 years

Secondary outcomes (5)

  1. Composite quality of Life

    Will be assessed by the Expanded Prostate Composite Index Short Form (EPIC-26) and will be compared between the 2 arms in terms of hormonal domain and sexual domain of EPIC-26. An area under the curve (AUC) metric will be utilized to account for the overall quality of life from baseline through 36 months for each patient. A mixed effect model will be employed to construct an estimate of the difference in AUC between Arms A and B, including fixed effects of time, arm, and baseline characteristics (two or three covariates depending on the available sample size). A two-sample t-test with a significance level of 0.05 will be performed.

    Measured: Up to 5 years

  2. Incidence of adverse events

    Will be assessed by Common Terminology Criteria for Adverse Events version 5.0 and will be reported descriptively.

    Measured: Up to 5 years

  3. Incidence of major adverse cardiovascular events

    Will be assessed by medical record review and will be reported descriptively.

    Measured: Up to 5 years

  4. Participant compliance

    Will be assessed by patient study diary.

    Measured: Up to 2 years

  5. Time to testosterone recovery

    Will be assessed by blood tests and the percentage of patients in each arm who achieved baseline level or minimum 280 ng/dL will be reported at 3-month intervals up through 36 months after treatment completion.

    Measured: Up to 5 years

Timeline

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

  1. First posted13 Nov 2023
  2. Study start20 Nov 2023 (estimated)
  3. Primary completion23 Oct 2025 (estimated)
  4. Study completion23 Oct 2026 (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
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06129851
Sponsor's protocol ID
STUDY00150674
Other IDs
NCI-2023-09079, STUDY00150674, P30CA168524
Status last verified
Nov 2023
First submitted
3 Nov 2023
Last updated
13 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Bone Scan and Brachytherapy in people with Stage IIC Prostate Cancer AJCC v8 and Stage III Prostate Cancer AJCC v8, run by University of Kansas Medical Center 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 20 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 13 Nov 2023. 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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemical recurrence (time frame: Up to 3 years). 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 NCT06129851.

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 13 Nov 2023.

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