Trial Title:
Relugolix in Combination With Radiation Therapy for Treating Patients With High Risk Prostate Cancer
NCT ID:
NCT06129851
Condition:
Stage IIC Prostate Cancer AJCC v8
Stage III Prostate Cancer AJCC v8
Stage IV Prostate Cancer AJCC v8
Conditions: Official terms:
Prostatic Neoplasms
Relugolix
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Arm A (relugolix, brachytherapy, external beam radiation)
Arm group label:
Arm B (relugolix, brachytherapy, external beam radiation)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Bone Scan
Description:
Undergo bone scan
Arm group label:
Arm A (relugolix, brachytherapy, external beam radiation)
Arm group label:
Arm B (relugolix, brachytherapy, external beam radiation)
Other name:
Bone Scintigraphy
Intervention type:
Radiation
Intervention name:
Brachytherapy
Description:
Undergo brachytherapy
Arm group label:
Arm A (relugolix, brachytherapy, external beam radiation)
Arm group label:
Arm B (relugolix, brachytherapy, external beam radiation)
Other name:
Brachytherapy, NOS
Other name:
Internal Radiation
Other name:
Internal Radiation Brachytherapy
Other name:
Internal Radiation Therapy
Other name:
Radiation Brachytherapy
Other name:
Radiation, Internal
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
Arm A (relugolix, brachytherapy, external beam radiation)
Arm group label:
Arm B (relugolix, brachytherapy, external beam radiation)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Procedure
Intervention name:
Dual X-ray Absorptiometry
Description:
Undergo DEXA scan
Arm group label:
Arm A (relugolix, brachytherapy, external beam radiation)
Arm group label:
Arm B (relugolix, brachytherapy, external beam radiation)
Other name:
BMD scan
Other name:
bone mineral density scan
Other name:
DEXA
Other name:
DEXA (Bone Density)
Other name:
DEXA Scan
Other name:
dual energy x-ray absorptiometric scan
Other name:
Dual Energy X-ray Absorptiometry
Other name:
Dual X-Ray Absorptometry
Other name:
DXA
Other name:
DXA SCAN
Intervention type:
Radiation
Intervention name:
External Beam Radiation Therapy
Description:
Undergo external beam radiation therapy
Arm group label:
Arm A (relugolix, brachytherapy, external beam radiation)
Arm group label:
Arm B (relugolix, brachytherapy, external beam radiation)
Other name:
Definitive Radiation Therapy
Other name:
EBRT
Other name:
External Beam Radiation
Other name:
External Beam Radiotherapy
Other name:
External Beam Radiotherapy (conventional)
Other name:
External Beam RT
Other name:
external radiation
Other name:
External Radiation Therapy
Other name:
external-beam radiation
Other name:
Radiation, External Beam
Other name:
Teleradiotherapy
Other name:
Teletherapy
Other name:
Teletherapy Radiation
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Arm A (relugolix, brachytherapy, external beam radiation)
Arm group label:
Arm B (relugolix, brachytherapy, external beam radiation)
Other name:
Magnetic Resonance
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Intervention type:
Procedure
Intervention name:
PSMA PET Scan
Description:
Undergo PSMA PET
Arm group label:
Arm A (relugolix, brachytherapy, external beam radiation)
Arm group label:
Arm B (relugolix, brachytherapy, external beam radiation)
Other name:
Prostate-specific Membrane Antigen PET
Other name:
PSMA PET
Other name:
PSMA-Positron emission tomography
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm A (relugolix, brachytherapy, external beam radiation)
Arm group label:
Arm B (relugolix, brachytherapy, external beam radiation)
Intervention type:
Drug
Intervention name:
Relugolix
Description:
Given PO
Arm group label:
Arm A (relugolix, brachytherapy, external beam radiation)
Arm group label:
Arm B (relugolix, brachytherapy, external beam radiation)
Other name:
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
Other name:
Orgovyx
Other name:
Relumina
Other name:
TAK 385
Other name:
TAK-385
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.
Detailed description:
PRIMARY OBJECTIVE:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
- 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:
- 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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Kansas Cancer Center
Address:
City:
Kansas City
Zip:
66160
Country:
United States
Contact:
Last name:
Xinglei Shen
Phone:
913-588-3600
Email:
xshen@kumc.edu
Investigator:
Last name:
Xinglei Shen
Email:
Principal Investigator
Start date:
November 20, 2023
Completion date:
October 23, 2026
Lead sponsor:
Agency:
University of Kansas Medical Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of Kansas Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06129851
