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A multi-centre, non-interventional study of relugolix in patients with advanced hormone-sensitive prostate cancer

RENAISSANCE - A multi-centre, non-interventional study of RElugolix as aNdrogen-deprivAtion therapy In patientS with advanced hormone-Sensitive prostate cANCEr

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN12004962
Enrollment
300
Registered
2026-03-30
Start date
2024-11-06
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer Cancer

Interventions

The participants' relugolix dose and regime will already be decided by their doctor and participating in this study will not alter this in any way. Patients will undergo clinical assessments and rec

Sponsors

Accord healthcare
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patient who had voluntarily signed and dated the informed consent form 2. Male patients aged 18 years or older 3. Patients who had histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate described in the patient’s file 4. Patients deemed eligible for androgen-deprivation therapy with relugolix prescribed as part of standard clinical practice. 5. Patient who has agreed with the investigator the initiation of relugolix, per the investigator's decision, prior to enrolment into the study 6. Intended duration of androgen-deprivation therapy of at least twelve months

Exclusion criteria

Exclusion criteria: 1. Patient unable to provide informed consent 2. History of surgical castration 3. Intended duration of androgen-deprivation therapy of less than 12 months 4. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the product information 5. Patient who has already received or is currently receiving relugolix 6. Participants who are not treated in line with current Summary of Product Characteristics for relugolix

Countries

England, France, Germany, Ireland, Italy, Romania, Spain, United Kingdom

Contacts

Public ContactBrigitta Hunter
brigitta.hunter@pharmexcel-cro.com+44 (0) 203 642 6654

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 17, 2026