Open Label Study of Relugolix in Men with Advanced Prostate Cancer
Research type
Research Study
Full title
HERO: A Multinational Phase 3 Randomized, Open-label, Parallel Group Study to Evaluate the Safety and Efficacy of Relugolix in Men with Advanced Prostate Cancer
IRAS ID
226687
Contact name
Salvatore Natale
Contact email
Sponsor organisation
Myovant Sciences GmbH
Eudract number
2017-000160-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 11 days
Research summary
Summary of Research
This study is to evaluate the safety and efficacy of Relugolix in men with advanced prostate cancer. Relugolix is an oral, once daily drug that reduces the levels of testosterone in the body. Lowering testosterone is known to help treat prostate cancer. \n\nIf prostate cancer is limited to the prostate gland and immediate surroundings only, this is normally treated with surgical removal of the prostate gland or with radiation therapy. If disease worsens after these therapies it is considered advanced prostate cancer. Approximately 1125 participants will participate worldwide with about 49 patients in the UK. The study has a screening period of up to 28 days, a study treatment period of 48 weeks and a safety follow up at 30 days post end of treatment, +60 and +90 days from post end of treatment for testosterone recovery (if applicable in some patients). The total duration will be about 15 months. Enrolled patients will be randomly assigned in a 2:1 ratio to receive Relugolix or Leuprolide Acetate. The study is open label so study teams and patients will know which arm they have been assigned to. Patients assigned to the Relugolix arm, will receive an oral dose of 360mg at day 1 (baseline) then 120mg once daily until end of week 48. Patients assigned to the Leuprolide Acetate 3-M will receive an injection of 22.5mg at day 1 (baseline) and at 12 week intervals over the 48 weeks. If indicated, patients on the Leuprolide Acetate arm may also receive an antiandrogen for 4 weeks or longer as decided by the investigator. \n\nThe study procedures include: medical history, vital signs, height and weight measurement, ECG, ECOG performance assessment, physical exam, questionnaires, and blood tests. Patients must have a bone scan and a CT or MRI within 60 days prior to randomization.\n
Summary of Results
What is this summary about?
This is a summary of a research study (known as a clinical trial) called HERO. The HERO study compared how well relugolix and leuprolide worked in lowering blood testosterone to sustained castration levels in men with advanced prostate cancer. Sustained castration is a blood testosterone level below 50 ng/dl from Day 29 through 48 weeks of treatment.What were the results?
Researchers looked at 930 adult men with advanced prostate cancer: 622 of these men took relugolix (by mouth once daily) and 308 received leuprolide (injected every 3 months). The HERO study showed that more men taking relugolix (97%) achieved sustained castration through 48 weeks than men receiving leuprolide (89%). This decrease in testosterone also happened more quickly in men taking relugolix. In 184 men who were followed up for 90 days after completing treatment, blood levels of testosterone returned to normal in more men who took relugolix than men who received leuprolide. Side effects were similar among men taking relugolix or receiving leuprolide, and most were identified as mild or moderate in terms of how bad they were.What do the results of the study mean?
In men with advanced prostate cancer and compared with those receiving leuprolide, more men taking relugolix had lower levels of blood testosterone.ClinicalTrials.gov NCT number: NCT03085095
Keywords:
advanced prostate cancer; androgen-deprivation therapy; clinical trial; GnRH agonist; GnRH antagonist; lay summary; leuprolide; plain language summary; relugolix https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbdMh5-2BpBzUX3s8iYIROHP-2BHb9KtAYMmSfPeTQN-2F3WsN3VGnFsRJ8XP4OgWEK81g-2B8k8vdi0rCkMMm9zUidTDLo4-3DmB0t_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YKC7IDSxOZv-2BJ7nm1yBwVILPIVOwtKT1Ty9G6RNfx2HQcqCca0Rw10fcBZSFc9NiTiVqK6Ialc0SGQCr3BBzYCdPDDLxi1PEqxX5qxbBCipW6jwBeRS-2Fz-2BCJ4RQbuUHU1TqJaz69wUGQHCahNDHsVgGKrJJYD0M2nGiCu82TNvjOw-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C3d05738458414e93d4fa08dad2df652a%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638054154166241083%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=4GgjbQ3hxhNgwkv34OnRRqwjf6%2BwwjFSVWFYl3ACulE%3D&reserved=0REC name
South Central - Oxford A Research Ethics Committee
REC reference
17/SC/0395
Date of REC Opinion
15 Sep 2017
REC opinion
Further Information Favourable Opinion