SBRT + Relugolix for Prostate Cancer
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Yale University
Must not be taking: QT prolonging drugs
Disqualifiers: Ulcerative colitis, Connective tissue disease, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?The goal of this clinical trial is to measure the toxicity and effectiveness of the following treatments for cFIR/cgUIR prostate cancer patients.
Stereotactic body radiotherapy (SBRT) alone or Stereotactic body radiotherapy (SBRT) combined with Ultrashort GNRH Antagonist called Relugolix (an oral drug). Treatments will be randomly assigned to study patients.
The main questions it aims to answer are the following:
1. Whether the proportion of men who undergo SUGAR have a superior rate of attaining PSA nadir of \<= 0.2 compared to SBRT alone, and
2. Whether SUGAR is superior to historical rates of minimal clinically important decline (MCID) in sexual and hormonal function at 6 months for patients undergoing 6 months of androgen deprivation therapy (ADT)
Men aged 18+ with cFIR/cgUIR will be enrolled. Specifically, patients must meet one of the following 2 criteria: 1) Gleason score must be Gleason 3+4 with a PSA \< 20 ng/mL, or 2) Gleason 6 (3+3) and PSA \> 10 ng/mL and \< 20 ng mL.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using medications that cause QT prolongation (a heart rhythm condition). It's best to discuss your current medications with the study team.
What data supports the effectiveness of the treatment SBRT + Relugolix for prostate cancer?
Research shows that stereotactic body radiation therapy (SBRT) is effective for treating localized and high-risk prostate cancer, with studies indicating good disease-free survival rates and potential benefits when combined with other therapies. Additionally, SBRT has been noted for its ability to enhance immune responses, suggesting it could work well with treatments like Relugolix, which is a hormone therapy used to lower testosterone levels in prostate cancer patients.
12345Is the combination of SBRT and Relugolix safe for treating prostate cancer?
The safety of SBRT (Stereotactic Body Radiation Therapy) for prostate cancer has been studied, showing some short-term side effects like urinary and bowel issues, but these are generally manageable. However, there is no specific safety data available for the combination of SBRT with Relugolix (a medication used to lower testosterone levels) in the provided research.
16789How is the treatment SBRT + Relugolix for prostate cancer different from other treatments?
SBRT (Stereotactic Body Radiation Therapy) combined with Relugolix is unique because it uses a high-dose, precise form of radiation therapy alongside a drug that lowers testosterone levels, which can enhance the effectiveness of the radiation. This combination may offer a more targeted approach with potentially fewer side effects compared to traditional treatments.
24101112Eligibility Criteria
Men aged 18+ with specific types of prostate cancer (cFIR/cgUIR) can join. They must have a Gleason score of 3+4 with PSA <20 ng/mL or Gleason 6 and PSA between >10 and <20 ng/mL. Excluded are those on recent investigational drugs, with heart issues like long QT syndrome, history of surgical castration, prior prostate cancer treatments, certain medication use, allergies to relugolix, inflammatory bowel diseases, connective tissue diseases or if GNRH/SBRT therapy is not suitable.Inclusion Criteria
I apologize, but without any specific information provided, I cannot rewrite or summarize the criterion for you. If you provide me with the details, I will be more than happy to help.
Exclusion Criteria
History of long QT syndrome documented in the medical record
You have had allergic reactions to relugolix in the past.
Treatment with another investigational drug or other intervention within 30 days of enrollment
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive SBRT and Relugolix or SBRT alone. Relugolix is administered for 30 days, starting 14 to 17 days prior to the first SBRT treatment.
6 weeks
Multiple visits for SBRT sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment, including quality of life assessments and PSA monitoring.
up to 2 years
Participant Groups
This trial tests the effectiveness and safety of SBRT alone versus SBRT combined with an oral drug called Relugolix in treating cFIR/cgUIR prostate cancer. It aims to see if combining these treatments improves PSA levels better than SBRT alone and assesses their impact on sexual and hormonal function at six months.
2Treatment groups
Active Control
Group I: Relugolix and SBRTActive Control2 Interventions
SBRT and Relugolix SBRT along with 30 days of total relugolix (study drug) will be used. Relugolix starting 14 days to 17 days prior to the first treatment.
Group II: Stereotactic body radiotherapyActive Control1 Intervention
SBRT Though a range of doses are delivered nationally for IR prostate cancer, the most common regimen is 7.25 Gy- 8.00 Gy x 5 fractions, given over 2 weeks.
Relugolix is already approved in United States, Japan, European Union for the following indications:
🇺🇸 Approved in United States as Orgovyx for:
- Advanced prostate cancer
- Uterine fibroids
🇯🇵 Approved in Japan as Relumina for:
- Uterine fibroids
🇪🇺 Approved in European Union as Orgovyx for:
- Advanced prostate cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Yale Cancer CenterNew Haven, CT
Memorial Sloan Kettering Cancer CenterNew York, NY
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Who Is Running the Clinical Trial?
Yale UniversityLead Sponsor
PfizerIndustry Sponsor
References
Stereotactic Body Radiotherapy for Clinically Localized Prostate Cancer: Toxicity and Biochemical Disease-Free Outcomes from a Multi-Institutional Patient Registry. [2022]To report on initial patient characteristics, treatment practices, toxicity, and early biochemical disease-free survival (bDFS) of localized prostate cancer treated with stereotactic body radiotherapy (SBRT) and enrolled in the RSSearch(®) Patient Registry.
Natural history of lower urinary tract symptoms among men undergoing stereotactic body radiation therapy for prostate cancer with and without a Rectal Hydrogel Spacer. [2022]Stereotactic body radiation therapy (SBRT) is increasingly used for prostate cancer, but has morbidity as both the bladder and rectum are radiated during treatment. Our goal was to document and compare lower urinary tract symptoms (LUTS) among men who underwent SBRT with and without SpaceOAR hydrogel (Augmenix, Inc., Bedford, MA).
Early outcomes of high-dose-rate brachytherapy combined with ultra-hypofractionated radiation in higher-risk prostate cancer. [2021]This study evaluated outcomes associated with a high-dose-rate (HDR) brachytherapy boost combined with stereotactic body radiation therapy (SBRT) for patients with higher-risk localized prostate cancer.
Translating the Immunobiology of SBRT to Novel Therapeutic Combinations for Advanced Prostate Cancer. [2020]Stereotactic body radiotherapy (SBRT) is an increasingly used radiation modality for the treatment of both localized and metastatic prostate cancer. Substantial data suggests that prostate cancer may be more sensitive to higher doses of radiation per fraction due to its low α/β ratio. This increased sensitivity raises important questions as to how SBRT should be combined with systemic therapy for clinically significant prostate cancer, including whether androgen deprivation therapy retains its beneficial effects when combined with SBRT. Furthermore, pre-clinical and clinical data suggest pronounced immunomodulatory effects of SBRT, including observed improvements in T cell priming and trafficking. These data support investigational strategies combining SBRT with immunotherapy. Here we aim to review the data for the use of SBRT in both the local and metastatic disease settings as well as ongoing translational and clinical research examining combinations with ADT, immunotherapy and other targeted agents.
Stereotactic Body Radiotherapy for High-Risk Localized Carcinoma of the Prostate (SHARP) Consortium: Analysis of 344 Prospectively Treated Patients. [2022]To explore the efficacy and toxicity of stereotactic body radiation therapy (SBRT) in high-risk prostate cancer (HRPCa) in a consortium of 7 institutional phase 2 trials and prospective registries.
Dose-Escalated Stereotactic Body Radiation Therapy for Patients With Intermediate- and High-Risk Prostate Cancer: Initial Dosimetry Analysis and Patient Outcomes. [2022]To report the short-term clinical outcomes and acute and late treatment-related genitourinary (GU) and gastrointestinal (GI) toxicities in patients with intermediate- and high-risk prostate cancer treated with dose-escalated stereotactic body radiation therapy (SBRT).
Dose-escalation of five-fraction SABR in prostate cancer: Toxicity comparison of two prospective trials. [2018]To compare biochemical outcome and toxicities of two prospective 5-fraction stereotactic ablative radiotherapy (SABR) studies in prostate cancer.
Dosimetric predictors of acute bowel toxicity after Stereotactic Body Radiotherapy (SBRT) in the definitive treatment of localized prostate cancer. [2023]SBRT is an increasingly popular treatment for localized prostate cancer, though considerable variation in technical approach is common and optimal dose constraints are uncertain. In this study, we sought to identify dosimetric and patient-related predictors of acute rectal toxicity.
Dosimetric predictors of toxicity and quality of life following prostate stereotactic ablative radiotherapy. [2021]SABR offers an effective treatment option for clinically localized prostate cancer. Here we report the dosimetric predictors of late toxicity and quality of life (QOL) in a pooled cohort of patients from four phase II trials.
Early Outcomes and Decision Regret Using PSMA/MRI-Guided Focal Boost for Prostate Cancer SBRT. [2022]Stereotactic body radiation therapy (SBRT) is a recognized treatment for low- and intermediate-risk prostate cancer, with 36.25 Gy in 5 fractions the most commonly used regimen. We explored the preliminary efficacy, patient recorded toxicity, and decision regret in intermediate- and high-risk prostate cancer receiving SBRT with prostate-specific membrane antigen (PSMA)/magnetic resonance imaging (MRI) guided focal gross tumor volume boost to 45 Gy.
Prostate stereotactic body radiotherapy with simultaneous integrated boost: which is the best planning method? [2022]The delivery of a simultaneous integrated boost to the intra-prostatic tumour nodule may improve local control. The ability to deliver such treatments with hypofractionated SBRT was attempted using RapidArc (Varian Medical systems, Palo Alto, CA) and Multiplan (Accuray inc, Sunnyvale, CA).
[Stereotactic body radiation therapy versus conventional intensity-modulated radiation therapy for the treatment of prostate cancer]. [2022]To explore the efficacy and toxicity of stereotactic body radiation therapy (SBRT) versus conventional intensity-modulated radiation therapy (IMRT) in the treatment of prostate cancer.