Apalutamide + Radiotherapy for Prostate Cancer
(PRIMORDIUM Trial)
Trial Summary
What is the purpose of this trial?
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.
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.
What data supports the effectiveness of the treatment Apalutamide + Radiotherapy for Prostate Cancer?
Research shows that combining hormone therapy, like LHRHa, with radiation therapy improves survival rates in prostate cancer patients by reducing the chances of the cancer returning or spreading. This suggests that using Apalutamide, a similar hormone therapy, with radiotherapy could also be effective.12345
Is the combination of Apalutamide and Radiotherapy safe for treating prostate cancer?
The combination of luteinizing hormone-releasing hormone (LHRH) analogs and external beam radiation therapy has been studied and found to be generally well tolerated, with low incidence of acute side effects like mild blood, intestinal, and urinary issues. Late side effects were rare, with only a few cases of rectal bleeding and chronic diarrhea reported.36789
How is the treatment of Apalutamide + Radiotherapy for Prostate Cancer different from other treatments?
This treatment is unique because it combines apalutamide, a new-generation anti-androgen that blocks male hormones, with radiotherapy to potentially improve the effectiveness of radiation in treating prostate cancer, especially in patients with advanced disease. This approach is different from traditional treatments that typically use older anti-androgens like bicalutamide.1231011
Research Team
Janssen Pharmaceutica N.V., Belgium Clinical Trial
Principal Investigator
Janssen Pharmaceutica N.V., Belgium
Eligibility Criteria
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
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
Treatment Details
Interventions
- Apalutamide
- LHRHa
- Radiotherapy
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
Biljana Naumovic
Janssen Pharmaceutica N.V., Belgium
Chief Medical Officer since 2019
MD from Belgrade University Medical School, Executive Education from London Business School