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Relugolix + Radiation for Advanced-Stage Prostate Cancer (NRG PROMETHEAN Trial)
NRG PROMETHEAN Trial Summary
This trial is testing whether a drug that lowers testosterone levels combined with radiation therapy can shrink tumors in patients with prostate cancer that has spread to 1 to 5 other parts of the body.
NRG PROMETHEAN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowNRG PROMETHEAN Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 trial • 29 Patients • NCT02045446NRG PROMETHEAN Trial Design
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- My prostate cancer has come back only in the lymph nodes in my pelvis.My hepatitis C is cured or undetectable while on treatment.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've been mostly active and able to care for myself in the last 4 months.I have severe heart failure.My hepatitis B virus load is undetectable with current treatment.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 1 to 5 small cancer spread areas in bones or soft tissues, confirmed by a PET scan within the last 4 months.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 have been diagnosed with prostate cancer.I have been cancer-free for over 3 years from any previous cancer.I cannot swallow whole pills.I do not have any health conditions that would stop me from completing the treatment.I am HIV positive, on treatment, and my viral load is undetectable.I have undergone treatment aimed at curing prostate cancer.I am 18 years old or older.
- Group 1: Arm I (placebo, SABR)
- Group 2: Arm II (relugolix, SABR)
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many individuals have enrolled in this clinical experiment?
"Affirmative. According to the information located on clinicaltrials.gov, this trial is in active recruitment mode since its inception on December 8th 2021. As of November 22nd 2022, 269 patients are needed from 85 distinct divisions for participation in this research project."
Could you assess the safety of Stereotactic Body Radiation Therapy for human subjects?
"Stereotactic Body Radiation Therapy has been assigned a rating of 2 based on the fact that there is only some supporting data regarding its safety and no evidence for its efficacy."
Are there numerous locales across North America that are facilitating this clinical trial?
"85 clinical trial sites are accepting patients, including Geisinger Wyoming Valley/Henry Cancer Center in Wilkes-Barre, Geisinger Cancer Services-Pottsville in Pottsville, and UH Seidman Cancer Center at Lake Health Mentor Campus in Mentor."
Is this experiment an unprecedented endeavor?
"As of now, there are seven ongoing trials for Stereotactic Body Radiation Therapy in 364 cities and 20 countries. This form of treatment first entered clinical testing back in 2018 with Myovant Sciences GmbH sponsoring the Phase 3 study that included 803 participants. Since then, a further 170 experiments have been conducted to support its efficacy."
What other research has been conducted regarding Stereotactic Body Radiation Therapy?
"Currently, seven Stereotactic Body Radiation Therapy (SBRT) studies are underway with three in Phase 3. Although the trials based out of Fort Collins, Colorado are the most prominent ones, 610 trial sites across the globe are conducting SBRT research."
Is recruitment still available for this research endeavor?
"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial is actively enrolling participants, with an initial posting date of December 8th 2021 and latest edit on November 22nd 2022. 269 candidates from 85 sites are needed for the study's completion."
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