Prostate Cancer study: Relugolix
Official title The SUGAR Study; SBRT and Relugolix) for Prostate Cancer
ClinicalTrials.gov ID: NCT06111781
What this study is testing
What is Relugolix 120 MG (Orgovyx)?
an investigational oral GnRH antagonist being studied as a potential treatment for prostate cancer is designed to block GnRH receptors, which reduces testosterone production
Also referred to as Orgovyx, Relugolix.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if combining focused radiation with a specific medication is more effective at lowering PSA levels than radiation alone. It also checks for any side effects.
- Who it's for
- Men with prostate cancer that is classified as clinically favorable or clinically grossly unfavorable intermediate risk.
- What's involved
- Participants will receive focused radiation therapy. Some will also take a daily oral medication called Relugolix. Patients are randomly assigned to one of these treatment groups.
- Time commitment
- The source text does not specify the total duration of the study or the number of required visits.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
- Born assigned to Male gender, age 18 and above. Female identifying transgender or gender fluid are allowed on study provided they have not undergone...
- Has a serum testosterone at the Screening visit of \>100 ng/dL
You likely can't join if
- Current use of medications that cause QT prolongation
- Known allergic reactions to relugolix
- Treatment with another investigational drug or other intervention for prostate cancer within 30 days of enrollment
- Ulcerative colitis or other inflammatory bowel disease history
- Connective tissue disease such as lupus, scleroderma, or dermatomyositis
- GNRH antagonist therapy or SBRT to the prostate are medically contraindicated or not tolerated
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
- Born assigned to Male gender, age 18 and above. Female identifying transgender or gender fluid are allowed on study provided they have not undergone testosterone suppressing therapy and were born with a prostate.
- Has a serum testosterone at the Screening visit of \>100 ng/dL
- Has a serum PSA concentration at the Screening visit of \> 0.2 ng/mL
- Able to swallow pills and take medication orally (no documented inability to eat solids and swallow pills) and be willing to adhere to the daily regimen of medication (if assigned to the experimental arm).
- For patients of reproductive potential: use of condoms or other methods (including abstinence) to ensure effective contraception with partner during radiotherapy and through 4 months after the last dose of the study...
- Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration
- Clinical favorable intermediate risk prostate cancer: Gleason score must be Gleason 3+4 with a PSA \ 10 ng/mL and \< 20 ng mL.
- Decipher GC score of 0.6 or higher or higher indicating high genomic risk for most recent biopsy
- Documented prostate volume (by MRI or ultrasound within 120 days or physician attestation within 120 days) \<= 80 cc
- Current use of medications that cause QT prolongation
- Known allergic reactions to relugolix
- Treatment with another investigational drug or other intervention for prostate cancer within 30 days of enrollment
- Ulcerative colitis or other inflammatory bowel disease history
- Connective tissue disease such as lupus, scleroderma, or dermatomyositis
- GNRH antagonist therapy or SBRT to the prostate are medically contraindicated or not tolerated
- History of long QT syndrome documented in the medical record
- Q-wave infarction unless identified 6 or more months before the Screening Visit
- QT interval corrected for heart rate (QTc) \> 470 msec. If the QTc is prolonged in a patient with a pacemaker, the patient may be enrolled in the study upon discussion with the study PI
- Congenital long QT syndromeQ
- History of surgical castration
- Prior treatment for prostate cancer with surgery or prostate directed radiotherapy
The study team makes the final eligibility decision.
Where it is enrolling
- New Haven, Connecticut, United States
- Lebanon, New Hampshire, United States
- New York, New York, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New Haven, Connecticut, United States; Lebanon, New Hampshire, United States; New York, New York, United States; Seattle, Washington, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.