Back to search results

Relugolix with Radiation for High-Risk Prostate Cancer

This study is looking at the best length of time to give relugolix along with radiation therapy for men with high-risk prostate cancer (Stage IIC, III, or IV). Relugolix is a medication that lowers testosterone, a hormone that can help prostate cancer grow. It is already approved by the FDA to treat prostate cancer. The study will compare giving relugolix for 12 months versus 24 months. Researchers want to see if one duration is better at preventing the cancer from returning (biochemical recurrence) and how it affects quality of life and side effects. About 90 men are planned to join this study. The current status of the study is unclear.

Study design
This is an interventional study where participants are randomly assigned to receive relugolix for either 12 or 24 months. It involves about 90 participants.
What's involved
You would take relugolix daily, undergo brachytherapy (a type of radiation) and external beam radiation, and have procedures like blood draws, bone scans, CT scans, and DEXA scans.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 3 years to check for biochemical recurrence.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06129851

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

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Kansas Medical Center
~90 participants
Updated 2023-11-13 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBone ScanBrachytherapyComputed TomographyDual X-ray AbsorptiometryExternal Beam Radiation Therapy

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Biochemical recurrence
Measured over Up to 3 years

Conditions

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

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Kansas1

Study leadership

  • Xinglei Shen · PRINCIPAL_INVESTIGATOR · University of Kansas

Who to contact

Xinglei Shen
[email protected]
913-588-3600
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Biochemical recurrenceUp to 3 years

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