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

NCT06129851 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: STUDY00150674NCI-2023-09079P30CA168524
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Stage IIC Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Biochemical recurrence

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

  Up to 3 years

Secondary Outcomes (5)

• Composite quality of Life

  Up to 5 years

• Incidence of adverse events

  Up to 5 years

• Incidence of major adverse cardiovascular events

  Up to 5 years

• Participant compliance

  Up to 2 years

• Time to testosterone recovery

  Up to 5 years

Study Arms (2)

Arm A (relugolix, brachytherapy, external beam radiation)

EXPERIMENTAL

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.

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)

EXPERIMENTAL

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.

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

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm A (relugolix, brachytherapy, external beam radiation); Arm B (relugolix, brachytherapy, external beam radiation)

Bone Scan PROCEDURE

Undergo bone scan

Also known as: Bone Scintigraphy

Arm A (relugolix, brachytherapy, external beam radiation); Arm B (relugolix, brachytherapy, external beam radiation)

Brachytherapy RADIATION

Undergo brachytherapy

Also known as: Brachytherapy, NOS, Internal Radiation, Internal Radiation Brachytherapy, Internal Radiation Therapy, Radiation Brachytherapy, Radiation, Internal

Arm A (relugolix, brachytherapy, external beam radiation); Arm B (relugolix, brachytherapy, external beam radiation)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography

Arm A (relugolix, brachytherapy, external beam radiation); Arm B (relugolix, brachytherapy, external beam radiation)

Dual X-ray Absorptiometry PROCEDURE

Undergo DEXA scan

Also known as: BMD scan, bone mineral density scan, DEXA, DEXA (Bone Density), DEXA Scan, dual energy x-ray absorptiometric scan, Dual Energy X-ray Absorptiometry, Dual X-Ray Absorptometry, DXA, DXA SCAN

Arm A (relugolix, brachytherapy, external beam radiation); Arm B (relugolix, brachytherapy, external beam radiation)

External Beam Radiation Therapy RADIATION

Undergo external beam radiation therapy

Also known as: Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy, External Beam Radiotherapy (conventional), External Beam RT, external radiation, External Radiation Therapy, external-beam radiation, Radiation, External Beam, Teleradiotherapy, Teletherapy, Teletherapy Radiation

Arm A (relugolix, brachytherapy, external beam radiation); Arm B (relugolix, brachytherapy, external beam radiation)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Arm A (relugolix, brachytherapy, external beam radiation); Arm B (relugolix, brachytherapy, external beam radiation)

PSMA PET Scan PROCEDURE

Undergo PSMA PET

Also known as: Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomography

Arm A (relugolix, brachytherapy, external beam radiation); Arm B (relugolix, brachytherapy, external beam radiation)

Questionnaire Administration OTHER

Ancillary studies

Arm A (relugolix, brachytherapy, external beam radiation); Arm B (relugolix, brachytherapy, external beam radiation)

Relugolix DRUG

Given PO

Also known as: 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, TAK-385

Arm A (relugolix, brachytherapy, external beam radiation); Arm B (relugolix, brachytherapy, external beam radiation)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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
• Prolonged echocardiogram corrected QT (QTc) interval \> 440 ns
• Prior pelvic therapy that would significantly overlap with radiation treatment fields
• Prior prostatectomy

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Specimen Handling; Brachytherapy; Absorptiometry, Photon; Bone Density; Congresses as Topic; Radiation; Magnetic Resonance Spectroscopy; Glutamate Carboxypeptidase II; relugolix

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Radiotherapy; Therapeutics; Radiography; Diagnostic Imaging; Densitometry; Photometry; Chemistry Techniques, Analytical; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Organizations; Health Care Economics and Organizations; Physical Phenomena; Spectrum Analysis; Carboxypeptidases; Exopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloexopeptidases; Metalloproteases

Study Officials

• Xinglei Shen

  University of Kansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 13, 2023
• Study Start: November 20, 2023
• Primary Completion: October 23, 2025
• Study Completion (Estimated): October 23, 2026
• Last Updated: November 13, 2023

Record last verified: 2023-11

Locations

US (1)