694 Participants Needed

Apalutamide + Radiotherapy for Prostate Cancer

(PRIMORDIUM Trial)

Recruiting at 188 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Male
Trial Phase: Phase 3
Sponsor: Janssen Pharmaceutica N.V., Belgium
Must be taking: LHRH agonists
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

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.12345

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.16789

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.1781011

Who Is on the Research Team?

JP

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

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.
See 4 more

Exclusion 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.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive radiotherapy and LHRH agonist, with or without apalutamide, for prostate cancer treatment

26 weeks
Regular visits as per treatment protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 9 years
Biannual visits for observational cohort

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?
3Treatment groups
Experimental Treatment
Active Control
Group I: Interventional Cohort (Group 2): RT+LHRHa + ApalutamideExperimental Treatment3 Interventions
Group II: Interventional Cohort (Group 1): RT+ LHRHaActive Control2 Interventions
Group III: Observational Cohort(Group3) PSMA-PET Negative ParticipantsActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Pharmaceutica N.V., Belgium

Lead Sponsor

Trials
84
Recruited
31,600+
Joaquin Duato profile image

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 profile image

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

In three clinical trials for locally advanced prostate cancer, combining external irradiation with LHRH analogues significantly improved various survival rates, including disease-free and overall survival, with a notable P-value of < 0.001.
The EORTC trial 22863 specifically demonstrated a significant overall survival benefit when using the LHRH analogue goserelin acetate from the start of irradiation for three years, while the RTOG trial 85-31 showed survival improvements in patients with poorly differentiated tumors when the LHRH analogue was started during the last week of irradiation.
[Current studies of combined radiotherapy-hormone therapy in localized and locally advanced prostatic cancers].Bolla, M., Artignan, X., Chirpaz, E., et al.[2019]
The SAVE trial is a Phase II study involving 202 men with advanced prostate cancer, comparing the effects of apalutamide combined with salvage radiotherapy against androgen-deprivation therapy plus salvage radiotherapy.
The primary goal is to evaluate sexual function after nine months of treatment, while also assessing quality of life, safety, and short-term efficacy of apalutamide, highlighting its potential benefits in managing prostate cancer post-surgery.
Phase II open-label study investigating apalutamide in patients with biochemical progression after radical prostatectomy.Dirix, P., Strijbos, M., den Mooter, TV., et al.[2021]
Apalutamide demonstrated stronger radio-sensitizing effects compared to bicalutamide in both hormone-sensitive and hormone-resistant prostate cancer cell lines, suggesting it may enhance the effectiveness of radiotherapy.
In vivo studies showed that combining apalutamide with radiotherapy resulted in significantly greater tumor necrosis in mouse models, indicating a potential for improved treatment outcomes in prostate cancer patients.
Apalutamide radio-sensitisation of prostate cancer.Kakouratos, C., Kalamida, D., Lamprou, I., et al.[2023]

Citations

Neoadjuvant hormone therapy for radical prostate radiotherapy: bicalutamide monotherapy vs. luteinizing hormone-releasing hormone agonist monotherapy: a single-institution matched-pair analysis. [2014]
[Current studies of combined radiotherapy-hormone therapy in localized and locally advanced prostatic cancers]. [2019]
External beam radiation therapy and abiraterone in men with localized prostate cancer: safety and effect on tissue androgens. [2022]
[Combination of radiotherapy and hormonotherapy in locally advanced cancers of the prostate]. [2019]
Nonrandomized Comparison of Efficacy and Side Effects of Bicalutamide Compared With Luteinizing Hormone-Releasing Hormone (LHRH) Analogs in Combination With Radiation Therapy in the CHHiP Trial. [2023]
[Neoadjuvant combined hormonal therapy and radiotherapy with external beam irradiation in prostatic carcinoma]. [2013]
Recovery of serum testosterone after neoadjuvant androgen deprivation therapy and radical radiotherapy in localized prostate cancer. [2022]
Intense androgen-deprivation therapy with abiraterone acetate plus leuprolide acetate in patients with localized high-risk prostate cancer: results of a randomized phase II neoadjuvant study. [2022]
Clinical and Biological Characterisation of Localised High-risk Prostate Cancer: Results of a Randomised Preoperative Study of a Luteinising Hormone-releasing Hormone Agonist with or Without Abiraterone Acetate plus Prednisone. [2021]
Phase II open-label study investigating apalutamide in patients with biochemical progression after radical prostatectomy. [2021]
Apalutamide radio-sensitisation of prostate cancer. [2023]
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