Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

PRIMORDIUM : A Randomized, Controlled, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With PSMA-PET-Positive Hormone-Sensitive Prostate Cancer, With an Observational Follow-up of PSMA-PET-Negative Patients

Male<br/>OnlyGender Male
Only

RecruitingStatus Recruiting

Multiple<Br/>Treatment TypesTypeMultiple
Treatment Types

ThreePhase Three

18+Age Over 18

Prostate<br/>CancersCancer LocationProstate
Cancers

Multiple treatment types,Radiotherapy,Systemic therapy | Urinary systemProstate

Trial Overview Read MoreRead more

This phase III trial is evaluating whether radiotherapy and LHRH agonist are a more effective treatment when also combined with apalutamide (hormone therapy) in people with prostate cancer.
 

This trial is treating patients with prostate cancer.

This is a radiotherapy and systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Randomized, Controlled, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With PSMA-PET-Positive Hormone-Sensitive Prostate Cancer, With an Observational Follow-up of PSMA-PET-Negative Patients

Commercial Sponsor

Janssen Pharmaceutica N.V., Belgium

Summary

This is a randomised, open-label trial which consists of two cohorts: interventional and observational. Within the intervention cohort, there are two groups: Group 1 (Active Comparator) will receive RT + LHRHa, and Group 2 (Experimental) will receive RT + LHRHa + Apalutamide. Eligible participants will undergo prostate-specific membrane antigen-positron emission tomography (PSMA-PET), whole-body Tc-bone scan, computed tomography (CT). Participants in Interventional Group 1 will receive RT with or without optional stereotactic body radiation therapy (SBRT), beginning 4 weeks after randomisation, along with LHRHa as a 3-monthly depot preparation within 3 days after randomisation and the end of Week 12, or as a 6-monthly depot preparation within 3 days after randomisation. Participants in Interventional Group 2 will receive RT with or without SBRT, beginning 4 weeks after randomisation, along with LHRHa as a 3-monthly depot preparation within 3 days after randomisation and the end of Week 12, or as a 6-monthly depot preparation within 3 days after randomisation. These participants will also receive 240mg of apalutamide starting within 3 days after randomisation, to be taken orally, once daily, for 180 days. Participants in the Observational Cohort will be those who are PSMA-PET-negative at screening. Data from this group will be collected in the course of routine clinical practice and will include clinical evaluations, disease progression, therapies administered as per standard-of-care at the study-sites and survival status.

Recruiting Hospitals Read MoreRead more

Epworth Freemasons, Medical Oncology
East Melbourne
Ms Amberlee Marker
amberlee.marker @epworth.org.au
03 9936 8056

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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