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LHRH Agonist

Apalutamide + Radiotherapy for Prostate Cancer (PRIMORDIUM Trial)

Phase 3
Waitlist Available
Research Sponsored by Janssen Pharmaceutica N.V., Belgium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be able to swallow whole the study drug tablets or follow the instructions for admixing with apple sauce
Biochemically recurrent prostate cancer after RP with a high risk of developing metastasis defined as pathological Gleason score greater than or equal to (>=) 8 evaluated from prostate tissue specimen at radical prostatectomy, OR PSADT less than or equal to (<=) 12 months at the time of screening
Must not have
Previous treatment with androgen deprivation therapy (ADT) for prostate cancer
History of pelvic radiation for malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 9 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is testing if adding a new medication to standard prostate cancer treatments can better delay the spread of cancer or death. The combination works by blocking male hormones, killing cancer cells, and lowering hormone levels.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Apalutamide may cause fatigue, rash, joint pain, falls, fractures, diarrhea, hot flushes, decreased appetite and weight loss among other side effects. Side effects from radiotherapy include skin irritation at the treated site and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can swallow pills whole or mix them with apple sauce.
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My prostate cancer has returned after surgery, with a high risk of spreading.
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My prostate cancer was confirmed through a tissue examination.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with hormone therapy for prostate cancer.
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I have had radiation treatment for cancer in my pelvic area.
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I am allergic or react badly to apalutamide, LHRH agonists, or their ingredients.
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I have had chemotherapy for prostate cancer.
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My scans show prostate cancer has spread.
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I have previously been treated with medications or surgery to lower my androgen levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 9 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 9 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Prostate specific Membrane Antigen-Positron Emission Tomography (PSMA-PET) Metastatic Progression-free Survival (ppMPFS)
Secondary study objectives
Number of Participants With Adverse Event (AE) and Serious Adverse Events (SAEs)
Overall Survival
PSA Levels at Week 26
+4 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Interventional Cohort (Group 2): RT+LHRHa + ApalutamideExperimental Treatment3 Interventions
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.
Group II: Interventional Cohort (Group 1): RT+ LHRHaActive Control2 Interventions
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.
Group III: Observational Cohort(Group3) PSMA-PET Negative ParticipantsActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiotherapy
2017
Completed Phase 3
~2610
LHRHa
2013
Completed Phase 2
~140
Apalutamide
2015
Completed Phase 2
~5660

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for prostate cancer, such as apalutamide, enzalutamide, and abiraterone, primarily target the androgen receptor pathway. Apalutamide and enzalutamide are androgen receptor inhibitors that block the binding of androgens to the receptor, inhibit the receptor's movement into the cell nucleus, and prevent its interaction with DNA. Abiraterone, on the other hand, inhibits the enzyme CYP17A1, which is involved in androgen production. These mechanisms are vital for prostate cancer patients as they disrupt the androgen signaling that drives cancer cell growth, thereby delaying disease progression and improving survival outcomes.

Find a Location

Who is running the clinical trial?

Janssen Pharmaceutica N.V., BelgiumLead Sponsor
80 Previous Clinical Trials
29,807 Total Patients Enrolled
2 Trials studying Prostate Cancer
3,214 Patients Enrolled for Prostate Cancer
Janssen Pharmaceutica N.V., Belgium Clinical TrialStudy DirectorJanssen Pharmaceutica N.V., Belgium
17 Previous Clinical Trials
3,653 Total Patients Enrolled

Media Library

LHRHa (LHRH Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04557059 — Phase 3
Prostate Cancer Research Study Groups: Interventional Cohort (Group 1): RT+ LHRHa, Observational Cohort(Group3) PSMA-PET Negative Participants, Interventional Cohort (Group 2): RT+LHRHa + Apalutamide
Prostate Cancer Clinical Trial 2023: LHRHa Highlights & Side Effects. Trial Name: NCT04557059 — Phase 3
LHRHa (LHRH Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04557059 — Phase 3
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