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LHRH Agonist
Apalutamide + Radiotherapy for Prostate Cancer (PRIMORDIUM Trial)
Phase 3
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 9 years
Awards & highlights
PRIMORDIUM Trial Summary
This triallooks at if adding a drug to radiation and hormone therapy can delay the spread of cancer in the body.
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.Check my eligibility
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.See study design
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.
PRIMORDIUM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow pills whole or mix them with apple sauce.
Select...
My prostate cancer has returned after surgery, with a high risk of spreading.
Select...
My prostate cancer was confirmed through a tissue examination.
Select...
I am fully active or can carry out light work.
PRIMORDIUM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 9 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 9 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Prostate specific Membrane Antigen-Positron Emission Tomography (PSMA-PET) Metastatic Progression-free Survival (ppMPFS)
Secondary outcome measures
Number of Participants With Adverse Event (AE) and Serious Adverse Events (SAEs)
Overall Survival
PSA Levels at Week 26
+4 morePRIMORDIUM 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
~3310
Find a Location
Who is running the clinical trial?
Janssen Pharmaceutica N.V., BelgiumLead Sponsor
78 Previous Clinical Trials
29,383 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
3,669 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with hormone therapy for prostate cancer.I have had radiation treatment for cancer in my pelvic area.I am allergic or react badly to apalutamide, LHRH agonists, or their ingredients.I can swallow pills whole or mix them with apple sauce.I had prostate surgery and my PSA was below 0.1 ng/mL between 6 and 20 weeks after.My scans show no signs of prostate cancer spread, except possibly one bone lesion.My prostate cancer has returned after surgery, with a high risk of spreading.My PSMA-PET scan shows at least one prostate cancer lesion in the pelvic area.I have had chemotherapy for prostate cancer.My prostate cancer was confirmed through a tissue examination.My scans show prostate cancer has spread.I have been treated for prostate cancer that came back after initial treatment.I am fully active or can carry out light work.I have previously been treated with medications or surgery to lower my androgen levels.
Research Study Groups:
This trial has the following groups:- Group 1: Interventional Cohort (Group 1): RT+ LHRHa
- Group 2: Observational Cohort(Group3) PSMA-PET Negative Participants
- Group 3: Interventional Cohort (Group 2): RT+LHRHa + Apalutamide
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What makes this clinical trial unique?
"There are 46 active clinical trials for Interventional Cohort (Group 2): RT+LHRHa + Apalutamide across 580 cities and 40 countries. Data suggests that the first trial was completed in 2013 by Aragon Pharmaceuticals, Inc. 1207 participants were involved and the study reached Phase 3 drug approval stage. In the 7 years since, 160 similar trials have been conducted."
Answered by AI
Are there other similar studies to Interventional Cohort (Group 2): RT+LHRHa + Apalutamide?
"Currently, there are 46 clinical trials underway for Interventional Cohort (Group 2): RT+LHRHa + Apalutamide. Of these, 16 are in Phase 3. Although many of the studies for Interventional Cohort (Group 2): RT+LHRHa + Apalutamide are based in Marshfield, Wisconsin, there are a total of 2752 locations across the world where these trials are taking place."
Answered by AI
Are new patients being recruited for this study?
"That is correct. The clinicaltrials.gov website indicates that this research project, which was first advertised on November 12th 2020, is looking for 412 individuals at a single site."
Answered by AI
Has the FDA approved a course of treatment that includes Interventional Cohort (Group 2): RT+LHRHa + Apalutamide?
"There is some evidence to support the efficacy of Interventional Cohort (Group 2): RT+LHRHa + Apalutamide, as this is a Phase 3 trial. Furthermore, there are multiple rounds of data that suggest it is safe, so it received a score of 3."
Answered by AI
How many people are part of this clinical trial at most?
"That is correct. As of 10/25/2022, the clinical trial indicated on clinicaltrials.gov was still recruiting patients. The posting dates for this study are 11/12/2020-10/25/2022 and it is seeking a total of 412 participants from 1 site location."
Answered by AI
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