Relugolix in Combination With Radiation Therapy for Treating Patients With High Risk Prostate Cancer
NCT ID: NCT06129851
Last Updated: 2023-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2023-11-20
2026-10-23
Brief Summary
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Detailed Description
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I. 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:
I. 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.
V. To compare the rate of testosterone recovery after 12 and 24 months of relugolix.
EXPLORATORY OBJECTIVE:
I. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A (relugolix, brachytherapy, external beam radiation)
Patients 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.
Biospecimen Collection
Undergo blood sample collection
Bone Scan
Undergo bone scan
Brachytherapy
Undergo brachytherapy
Computed Tomography
Undergo CT
Dual X-ray Absorptiometry
Undergo DEXA scan
External Beam Radiation Therapy
Undergo external beam radiation therapy
Magnetic Resonance Imaging
Undergo MRI
PSMA PET Scan
Undergo PSMA PET
Questionnaire Administration
Ancillary studies
Relugolix
Given PO
Arm B (relugolix, brachytherapy, external beam radiation)
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.
Biospecimen Collection
Undergo blood sample collection
Bone Scan
Undergo bone scan
Brachytherapy
Undergo brachytherapy
Computed Tomography
Undergo CT
Dual X-ray Absorptiometry
Undergo DEXA scan
External Beam Radiation Therapy
Undergo external beam radiation therapy
Magnetic Resonance Imaging
Undergo MRI
PSMA PET Scan
Undergo PSMA PET
Questionnaire Administration
Ancillary studies
Relugolix
Given PO
Interventions
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Biospecimen Collection
Undergo blood sample collection
Bone Scan
Undergo bone scan
Brachytherapy
Undergo brachytherapy
Computed Tomography
Undergo CT
Dual X-ray Absorptiometry
Undergo DEXA scan
External Beam Radiation Therapy
Undergo external beam radiation therapy
Magnetic Resonance Imaging
Undergo MRI
PSMA PET Scan
Undergo PSMA PET
Questionnaire Administration
Ancillary studies
Relugolix
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
* 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
Exclusion Criteria
* 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
* Prolonged echocardiogram corrected QT (QTc) interval \> 440 ns
* Prior pelvic therapy that would significantly overlap with radiation treatment fields
* Prior prostatectomy
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Kansas Medical Center
OTHER
Responsible Party
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Xinglei Shen
Principal Investigator
Principal Investigators
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Xinglei Shen
Role: PRINCIPAL_INVESTIGATOR
University of Kansas
Locations
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University of Kansas Cancer Center
Kansas City, Kansas, United States
Countries
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Facility Contacts
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Other Identifiers
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NCI-2023-09079
Identifier Type: REGISTRY
Identifier Source: secondary_id
STUDY00150674
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00150674
Identifier Type: -
Identifier Source: org_study_id
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