Apalutamide + Radiotherapy for Prostate Cancer
(PRIMORDIUM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether adding the drug apalutamide to standard prostate cancer treatment can delay disease spread or improve survival. It targets men who have undergone prostate surgery and still show signs of cancer, specifically those with rising PSA levels (a protein indicating prostate activity) after surgery. Participants will receive either standard treatment with radiotherapy (also known as radiation therapy or X-ray therapy) and hormone therapy (LHRHa), or the same treatment plus apalutamide. This trial may suit those who have had prostate cancer surgery, are experiencing rising PSA levels, and have not previously received radiation or hormone therapy for this condition. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in prostate cancer treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on certain medications like androgen receptor antagonists or CYP17 inhibitors, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that apalutamide, the medication tested with radiotherapy, has been generally safe in earlier trials. Real-world studies have confirmed that apalutamide is safe and effective for patients with prostate cancer. In some studies, a very small number of patients, about 0.2%, experienced serious issues like problems with blood flow in the brain, but these were rare.
Radiotherapy has long been a common treatment for prostate cancer. It is known to be effective, and most patients tolerate it well. Common side effects might include tiredness and skin irritation, but these are usually manageable.
Overall, both apalutamide and radiotherapy have been well-tolerated in past studies, providing reassurance about their safety in clinical trials.12345Why are researchers excited about this study treatment for prostate cancer?
Researchers are excited about the combination of apalutamide with radiotherapy for prostate cancer because it introduces a potentially powerful synergy. Unlike the standard of care, which often includes treatments like surgery, radiation, and hormone therapy alone, this approach combines radiotherapy with apalutamide, an advanced androgen receptor inhibitor. Apalutamide works by blocking the effects of male hormones that can fuel cancer growth, and when paired with radiotherapy, it might enhance the effectiveness of cancer cell eradication. Additionally, the study is exploring different combinations with or without the drug to understand its added benefits, aiming to improve outcomes for patients by offering a more comprehensive attack on the cancer.
What evidence suggests that this trial's treatments could be effective for prostate cancer?
In this trial, one group of participants will receive apalutamide combined with radiotherapy and hormone therapy (LHRHa). Studies have shown that apalutamide can significantly improve survival rates in prostate cancer patients. Specifically, one study found that 65.1% of patients taking apalutamide with hormone therapy (ADT) were alive after 48 months, compared to 51.8% of those taking a placebo with ADT. Research indicates that apalutamide can reduce the risk of death by 23% over two years in men with prostate cancer that has spread but still responds to hormone therapy. Both real-world use and clinical trials have deemed it safe. Adding apalutamide to radiation treatment may help delay cancer spread, as it effectively slows prostate cancer progression.25678
Who Is on the Research Team?
Janssen Pharmaceutica N.V., Belgium Clinical Trial
Principal Investigator
Janssen Pharmaceutica N.V., Belgium
Are You a Good Fit for This Trial?
Men with high-risk, hormone-sensitive prostate cancer who've had a prostatectomy and show no signs of metastasis. They must have a PSA <0.1 ng/mL post-surgery, good performance status (able to carry out daily activities), and be at high risk for metastasis based on specific criteria like Gleason score or PSADT. Participants need to swallow pills and undergo PSMA-PET scans.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive radiotherapy and LHRH agonist, with or without apalutamide, for prostate cancer treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Apalutamide
- LHRHa
- Radiotherapy
Trial Overview
The trial is testing if adding Apalutamide to standard treatment with Radiotherapy plus LHRH agonist can delay the spread of cancer or death in men with high-risk prostate cancer. The effectiveness will be measured using advanced imaging techniques like PSMA-PET.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Participants will receive prostate-bed plus pelvic lymph node salvage external-beam radiotherapy (RT) with or without optional stereotactic body radiation therapy (SBRT), along with a LHRHa as a 3-monthly depot preparation within 3 days after randomization and the end of Week 12, or as a 6-monthly depot preparation within 3 days after randomization. Participants will also receive 240 milligram (mg) of apalutamide starting within 3 days after randomization as film-coated tablets, to be swallowed whole and together once daily with or without food, for a period of 180 Days.
Participants will receive radiotherapy (RT) which is defined as prostate-bed plus pelvic lymph node salvage external-beam radiotherapy with or without optional stereotactic body radiation therapy (SBRT), along with a luteinizing hormone-releasing hormone agonist (LHRHa) as a 3-monthly depot preparation within 3 days after randomization and the end of Week 12, or as a 6-monthly depot preparation within 3 days after randomization.
Enrollment into this cohort will be stopped further. Participants who were PSMA-PET-negative at screening and were already enrolled in the Observational Cohort will continue in this cohort. Data collected in the course of routine clinical practice during this period will include clinical evaluations, disease progression, therapies administered as per standard-of-care at the study-sites and survival status. For Observational Cohort, information will be entered into the electronic case report form (eCRF) from the medical records at least twice a year. The use of any medicinal product(s) for the treatment and management of participants will be at discretion of the treating physician.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Pharmaceutica N.V., Belgium
Lead Sponsor
Joaquin Duato
Janssen Pharmaceutica N.V., Belgium
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Pharmaceutica N.V., Belgium
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University
Published Research Related to This Trial
Citations
ERLEADA® (apalutamide) demonstrates statistically ...
Largest head-to-head real-world study in mCSPC demonstrated that ERLEADA® reduced risk of death by 23 percent at 24 months compared to ...
Efficacy | ERLEADA® (apalutamide) HCP
Median follow-up time was 44.0 months. 1. The survival rate at 48 months was 65.1% for ERLEADA ® + ADT patients vs 51.8% for placebo + ADT patients.
Survival outcomes of apalutamide as a starting treatment
Starting treatment with APA + ADT was associated with a significantly reduced risk of death compared with ENZ + ADT (aHR, 95%CI) (0.66, 0.51– ...
Real-world clinical usage and efficacy of apalutamide in ...
The secondary outcomes were the efficacy of apalutamide: PSA response (50% or 90% decline), progression-free survival, and skin-adverse events ( ...
Apalutamide in Metastatic Castration-sensitive Prostate ...
Our results show that apalutamide is a safe and effective drug in the real-world setting as well as in clinical trials.
PATIENT-REPORTED OUTCOMES FOR HRQoL 1-6
Across the SPARTAN and TITAN studies, 3 patients (0.2%) treated with ERLEADA® and 2 patients (0.2%) treated with placebo died from a cerebrovascular event.
Results from the Multicenter Real-world ARON-3 Study
Our results show that apalutamide is a safe and effective drug in the real-world setting as well as in clinical trials.
Apalutamide for Metastatic, Castration-Sensitive Prostate ...
In our trial, initial therapy with apalutamide in patients with metastatic, castration-sensitive prostate cancer led to improved clinical outcomes. The intent ...
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