Relugolix + Radiation for Advanced-Stage Prostate Cancer (NRG PROMETHEAN Trial)
Palo Alto (17 mi)Overseen byBridget F Koontz
Age: 18+
Sex: Male
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: NRG Oncology
Prior Safety Data
Trial Summary
What is the purpose of this trial?This phase II trial tests whether relugolix and radiation therapy works to shrink tumors in patients with prostate cancer that has spread in a limited way to 1 to 5 other parts of the body (oligometastatic). Testosterone can cause the growth of prostate cancer cells. Relugolix lowers the amount of testosterone made by the body. This may help stop the growth of tumor cells that need testosterone to grow. Giving relugolix with radiation therapy may help lower the chance of prostate cancer growing or spreading.
Is the drug Relugolix combined with Stereotactic Body Radiation Therapy a promising treatment for advanced-stage prostate cancer?Yes, Relugolix combined with Stereotactic Body Radiation Therapy is promising for advanced-stage prostate cancer. Relugolix is an oral drug that quickly lowers testosterone levels, which helps slow cancer growth. It is easy to take and may have fewer heart-related side effects compared to other treatments. When used with targeted radiation therapy, it can effectively manage the disease.568910
What safety data exists for Relugolix + Radiation in prostate cancer treatment?The safety data for stereotactic ablative radiotherapy (SABR) using CyberKnife in prostate cancer treatment shows promising results. Studies report that SABR is effective for localized prostate cancer, with some patients experiencing genitourinary toxicity. In one study, 4 patients had Grade 2 acute genitourinary toxicity, and 2 had Grade 3. Another study found that SABR-related genitourinary toxicity rates were evaluated, and dosimetric predictors of late toxicity and quality of life were identified. Overall, the treatment appears to be safe with manageable side effects.12347
What data supports the idea that Relugolix + Radiation for Advanced-Stage Prostate Cancer is an effective treatment?The available research shows that Relugolix, when combined with radiation, is effective for treating advanced-stage prostate cancer. In the HERO study, Relugolix was shown to suppress testosterone levels effectively, which is important for controlling prostate cancer. It was found to be as effective as another treatment, leuprolide, and even showed potential benefits in terms of heart health. Additionally, Relugolix offers the convenience of being an oral medication, which can be easier for patients to take compared to injections. This makes it a valuable option for those needing androgen deprivation therapy.568910
Do I need to stop my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on androgen deprivation or anti-androgen therapy to participate.
Eligibility Criteria
Men aged 18+ with advanced-stage prostate cancer that has spread to a limited number of other body parts (1-5 sites). They must have had prior treatment for prostate cancer, no severe comorbidities preventing protocol completion, and agree to use effective contraception. Excluded are those with only intrapelvic lymph node recurrence or certain heart conditions.Inclusion Criteria
My hepatitis C is cured or undetectable while on treatment.
My hepatitis B virus load is undetectable with current treatment.
I have 1 to 5 small cancer spread areas in bones or soft tissues, confirmed by a PET scan within the last 4 months.
I have been diagnosed with prostate cancer.
I have undergone treatment aimed at curing prostate cancer.
I am 18 years old or older.
Exclusion Criteria
My prostate cancer has come back only in the lymph nodes in my pelvis.
I have had radiation therapy on a cancerous lesion.
I have inflammatory bowel disease and am planned for radiotherapy in the abdomen or pelvis area.
I have severe heart failure.
My prostate cancer diagnosis was confirmed by a biopsy.
I am currently receiving hormone therapy for my cancer.
I have a stomach or intestine problem that affects how I absorb pills.
I have had chemotherapy for prostate cancer or have undergone surgical removal of both testicles.
I have severe or unpredictable chest pain.
My cancer has returned in the prostate area after radiation treatment.
My cancer has spread to my brain, spinal cord, or internal organs.
I have a history of long QT syndrome.
Radiotherapy cannot target all my cancer spread sites.
I cannot swallow whole pills.
Treatment Details
The trial is testing if adding Relugolix to usual radiation therapy can shrink tumors in men with oligometastatic prostate cancer. Relugolix lowers testosterone which may inhibit tumor growth. Participants will either receive Relugolix or a placebo alongside their radiation treatments.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm II (relugolix, SABR)Experimental Treatment3 Interventions
Patients receive relugolix PO QD on days 1-180 and undergo SABR for 1-3 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (placebo, SABR)Placebo Group3 Interventions
Patients receive placebo PO QD on days 1-180 and undergo SABR for 1-3 weeks in the absence of disease progression or unacceptable toxicity.
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:
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusYpsilanti, MI
Bryn Mawr HospitalBryn Mawr, PA
University of Colorado HospitalAurora, CO
East Jefferson General HospitalMetairie, LA
More Trial Locations
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Who is running the clinical trial?
NRG OncologyLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Dosimetric and patient correlates of quality of life after prostate stereotactic ablative radiotherapy. [2018]Initial results of Stereotactic Ablative Body Radiotherapy (SABR) in the treatment of localized prostate cancer appear promising however long-term quality of life (QOL) outcomes and dosimetric correlates are necessary.
Cyberknife treatment for low and intermediate risk prostate cancer. [2015]Cyberknife is an emerging treatment for early stage prostate cancer. Between October 2012 and January 2014, 32 patients were treated in our institution. Prescribed dose was 35-36.25 Gy in five fractions. Biochemical response was observed in 22 patients. Four patients experienced G2 acute genitourinary toxicity and in two cases we recorded G3 acute GU toxicity. 5 patients experienced G2 acute proctitis. At last follow up visit, all patients were still alive. 29 remained free of disease at last follow up appointment, while three developed a biochemical recurrence. Our experience confirms the efficacy and safety of Cyberknife for localized prostate cancer.
Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. [2017]Recent clinical reports of stereotactic ablative radiotherapy (SABR) in the treatment of low-risk prostate cancer have been encouraging. Our study evaluates the efficacy and safety of SABR using the CyberKnife system for treating intermediate- to very-high-risk prostate cancer.
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.
The Oral Gonadotropin-releasing Hormone Receptor Antagonist Relugolix as Neoadjuvant/Adjuvant Androgen Deprivation Therapy to External Beam Radiotherapy in Patients with Localised Intermediate-risk Prostate Cancer: A Randomised, Open-label, Parallel-group Phase 2 Trial. [2023]External beam radiotherapy (EBRT) with neoadjuvant/adjuvant androgen deprivation therapy (ADT) is an established treatment option to prolong survival for patients with intermediate- and high-risk prostate cancer (PCa). Relugolix, an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, was evaluated in this clinical setting in comparison with degarelix, an injectable GnRH antagonist.
Relugolix: A Review in Advanced Prostate Cancer. [2023]Relugolix (Orgovyx®), an orally active nonpeptide gonadotropin-releasing hormone (GnRH) receptor antagonist that provides rapid testosterone suppression, is indicated in the USA for the treatment of advanced prostate cancer and in the EU for advanced hormone-sensitive prostate cancer. In the pivotal phase III HERO trial in men with advanced prostate cancer, once-daily oral relugolix (with a loading dose on day 1) led to a sustained castration rate over 48 weeks of treatment of > 90%, a rate that was non-inferior to that provided by intramuscular leuprolide depot every 3 months (with an exploratory analysis further indicating the superiority of relugolix over leuprolide). Relugolix was generally well tolerated, having an adverse event profile that is consistent with testosterone suppression. Furthermore, there is evidence that relugolix may be associated with a lower risk of major adverse cardiac events compared with leuprolide. With the ability to provide the rapid testosterone suppression (with no initial surge in testosterone upon treatment initiation) combined with the benefits of oral administration and potentially improved cardiac safety, relugolix presents a valuable treatment option for men with advanced prostate cancer where androgen deprivation therapy is indicated.
Stereotactic body radiation therapy for prostate cancer: a study comparing 3-year genitourinary toxicity between CyberKnife and volumetric-modulated arc therapy by propensity score analysis. [2023]To investigate whether the rate of stereotactic body radiation therapy-related (SBRT-related) genitourinary (GU) toxicity is lower in patients with prostate cancer treated with CyberKnife.
A Practical Guide to Relugolix: Early Experience With Oral Androgen Deprivation Therapy. [2023]Relugolix is the newest form of androgen deprivation therapy (ADT) approved for prostate cancer. However, as an oral drug, several real-world concerns exist, particularly medication compliance, safety with other androgen receptor-targeted agents, and financial burden to patients.
Impact of Relugolix Versus Leuprolide on the Quality of Life of Men with Advanced Prostate Cancer: Results from the Phase 3 HERO Study. [2023]Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, demonstrated testosterone suppression to castrate levels in men with advanced prostate cancer (PCa) in the HERO study. Since advanced PCa and its treatments can impact patients' daily life, it is imperative to understand the impact of systemic therapy on patient health-related quality of life (HRQOL).
Early biochemical outcomes following neoadjuvant/adjuvant relugolix with stereotactic body radiation therapy for intermediate to high risk prostate cancer. [2023]Injectable GnRH receptor agonists have been shown to improve cancer control when combined with radiotherapy. Prostate SBRT offers an abbreviated treatment course with comparable efficacy to conventionally fractionated radiotherapy. Relugolix is a new oral GnRH receptor antagonist which achieves rapid, sustained testosterone suppression. This prospective study sought to evaluate early testosterone suppression and PSA response following relugolix and SBRT for intermediate to high prostate cancer.