Skip to content

SOCRATES PILOT: Standard of Care Randomised Treatment Evaluation Studies

SOCRATES PILOT: Standard of Care Randomised Treatment Evaluation Studies

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000110583
Acronym
SOCRATES PILOT
Enrollment
14
Registered
2024-02-08
Start date
2024-08-19
Completion date
2026-01-31
Last updated
2025-09-08

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

Conditions

None listed

Brief summary

The SOCRATES pilot study aims to assess the feasibility of randomising different Standard of Care (SoC) treatment options for a range of medical conditions listed below. 1) Recurrent glioblastoma 2) Non-metastatic castration-resistant prostate cancer 3) Metastatic castration-resistant prostate cancer 4) Metastatic castration-sensitive prostate cancer 5) Maintenance PARPinhibitor for primary ovarian cancer with BRCA mutation 6) Adjuvant Treatment for ER+ early breast cancer in post-menopausal women 7) HER2-negative advanced breast cancer after failure of anthracycline 8) Deep vein thrombosis (DVT) 9) Post Myocardial Infarction (MI) 10) People with office BP>120/80 and <150/90 in the setting of primary prevention of cardiovascular disease (CVD) 11) Non-valvular atrial fibrillation 12) Previous Myocardial Infarction (MI)/Stroke 13) Heart Failure with Reduced Ejection Fraction (HFrEF) without Diabetes mellitus (DM) 14) Hospital admission with first episode paroxysmal Atrial Fibrillation (AF) "Standard of care" refers to the treatment that a patient would usually be given for their health condition and is recommended by experts and scientific studies. There may be more than one SoC treatment for a medical condition. Who is it for? You can participate in this study if your medical condition is listed above and there is more than one standard of care options available for your health condition. Based on your own preference, you will either be a member of the randomised cohort or the non-randomised cohort. Participants in the randomised cohort will have their SoC option specified by a randomisation system. Participants in the non-randomised cohort will directly choose their SoC option in collaboration with their doctor. The study will also collect information on participant's experiences receiving the SoC option, as well as collect information on outcomes associated with the treatment they receive. The study plans to enrol approximately 200 participants in Australia.

Interventions

The SOCRATES pilot study aims to assess the feasibility of randomising different Standard of Care (SoC) treatment options for a range of medical conditions. "Standard of care" refers to the treatment that a patient would usually be given for their health condition and is recommended by experts and scientific studies. There may be more than one SoC treatment for a medical condition. The medical conditions and SoC options included in this study are: 1) Recurrent glioblastoma SoC 1. Lomustine alo

The SOCRATES pilot study aims to assess the feasibility of randomising different Standard of Care (SoC) treatment options for a range of medical conditions. "Standard of care" refers to the treatment that a patient would usually be given for their health condition and is recommended by experts and scientific studies. There may be more than one SoC treatment for a medical condition. The medical conditions and SoC options included in this study are: 1) Recurrent glioblastoma SoC 1. Lomustine alone SoC 2. Bevacizumab alone 2) Non-metastatic castration-resistant prostate cancer SoC 1. Darolutamide SoC 2. Apalutamide SoC 3. Enzalutamide 3) Metastatic castration-resistant prostate cancer SoC 1. Abiraterone and prednis(ol)one SoC 2. Enzalutamide 4) Metastatic castration-sensitive prostate cancer SoC 1. Apalutamide SoC 2. Enzalutamide 5) Maintenance PARPinhibitor for primary ovarian cancer with BRCA mutation SoC 1. Olaparib SoC 2. Niraparib 6) Adjuvant Treatment for ER+ early breast cancer in post-menopausal women SoC 1. Letrozole SoC 2. Anastrozole 7) HER2-negative advanced breast cancer after failure of anthracycline SoC 1. Paclitaxel SoC 2. Nab-Paclitaxel 8) Deep vein thrombosis (DVT) SoC 1. Rivaroxaban SoC 2. Apixaban 9) Post Myocardial Infarction (MI) SoC 1. Cardiac rehab via telehealth SoC 2. Cardiac rehab in person 10) People with office BP>120/80 and <150/90 in the setting of primary prevention of cardiovascular disease (CVD) SoC 1. Changes to lifestyle (nutrition, physical activity and smoking status) SoC 2. BP lowering medications (any ACE inhibitor or Angiotensin II receptor blocker, dose discretionary) 11) Non-valvular atrial fibrillation SoC 1. Rivaroxaban SoC 2. Apixaban 12) Previous Myocardial Infarction (MI)/Stroke SoC 1. Atorvastatin SoC 2. Rosuvastatin 13) Heart Failure with Reduced Ejection Fraction (HFrEF) without Diabetes mellitus (DM) SoC 1. Empagliflozin SoC 2. Dapagliflozin 14) Hospital admission with first episode paroxysmal Atrial Fibrillation (AF) SoC 1. Metoprolol SoC 2. Sotalol Participants will discuss the SoC options for their medical condition with their doctor. If the doctor recommends more than one SoC option for this participant, they would be invited to participate in the Study. Based on their own preference, participants will either have their SoC option determined by randomisation (randomised cohort) or they will choose their SoC option in consultation with their doctor (non-randomised cohort). The randomized cohort is the 'intervention' group for SOCRATES pilot study. The recruitment period is of two years. Each recruited study participant will be followed up for twelve months post registration to the study.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Adults, aged 18 years and older. 2. Have one of the defined medical conditions as listed in 'Step 3: Intervention/exposure' of this Registration Form. Medical conditions: 1) Recurrent glioblastoma 2) Non-metastatic castration-resistant prostate cancer 3) Metastatic castration-resistant prostate cancer 4) Metastatic castration-sensitive prostate cancer 5) Maintenance PARPinhibitor for primary ovarian cancer with BRCA mutation 6) Adjuvant Treatment for ER+ early breast cancer in post-menopausal women 7) HER2-negative advanced breast cancer after failure of anthracycline 8) Deep vein thrombosis (DVT) 9) Post Myocardial Infarction (MI) 10) People with office BP>120/80 and <150/90 in the setting of primary prevention of cardiovascular disease (CVD) 11) Non-valvular atrial fibrillation 12) Previous Myocardial Infarction (MI)/Stroke 13) Heart Failure with Reduced Ejection Fraction (HFrEF) without Diabetes mellitus (DM) 14) Hospital admission with first episode paroxysmal Atrial Fibrillation (AF) 3. Be considered suitable – by their responsible clinician - for at least 2 SoC options for this condition based on evidence-based guidelines or other appropriate documentation listed in 'Step 3: Intervention/exposure' of this Registration Form. 4. Give informed consent to either be assigned a SoC option (randomised cohort) or receive their chosen SoC option (non-randomised cohort) and to have routinely collected clinical outcome information in their medical record made available in a de-identified manner centrally for the study. 5. Consent to simple web-based questionnaire follow-up (not compulsory).

Exclusion criteria

1. Unable to provide informed consent. 2. Contraindication to any of the nominated SoC options.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026