Hormone + Radiation Therapy for Prostate Cancer
Trial Summary
What is the purpose of this trial?
This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy treatment may work the same at controlling prostate cancer compared to the usual 24 month hormone therapy treatment in patients with low gene risk score. Adding apalutamide to the usual treatment may increase the length of time without prostate cancer spreading as compared to the usual treatment in patients with high gene risk score.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop all current medications, but if you are taking a 5-alpha reductase inhibitor, you should stop it before randomization. Additionally, if you are in the Intensification Cohort, you must stop or substitute medications that lower the seizure threshold at least 30 days before randomization.
What data supports the effectiveness of the treatment involving hormone and radiation therapy for prostate cancer?
Research shows that combining hormone therapy with radiation can improve prostate cancer control. For instance, adding bicalutamide to radiotherapy significantly improves survival in locally advanced prostate cancer. Additionally, abiraterone acetate with prednisone has been shown to improve survival in metastatic cases.12345
Is hormone and radiation therapy for prostate cancer safe for humans?
How does the hormone and radiation therapy treatment for prostate cancer differ from other treatments?
This treatment combines hormone therapy with radiation therapy, using a variety of drugs like Abiraterone Acetate and Apalutamide, which are known for their effectiveness in blocking androgens (male hormones) that fuel prostate cancer growth. The combination aims to improve tumor control and survival rates compared to radiation alone, although it may come with more side effects.25111213
Research Team
Paul L Nguyen
Principal Investigator
NRG Oncology
Eligibility Criteria
Men over 18 with high-risk prostate cancer, no metastatic disease outside the pelvis, and a good performance status can join. They must have had no prior chemotherapy for prostate cancer in the last 3 years, no radical prostatectomy or pelvic radiotherapy, and not be on certain medications like 5-alpha reductase inhibitors at randomization.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo radiation therapy over 2-11 weeks and receive androgen deprivation therapy (ADT) for 12 or 24 months, with or without apalutamide, depending on genomic risk score.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including imaging and blood sample collection.
Treatment Details
Interventions
- Abiraterone Acetate (Hormone Therapy)
- Apalutamide (Androgen Receptor Antagonist)
- Bicalutamide (Hormone Therapy)
- Buserelin (Hormone Therapy)
- Degarelix (Hormone Therapy)
- Flutamide (Hormone Therapy)
- Goserelin (Hormone Therapy)
- Histrelin (Hormone Therapy)
- Leuprolide (Hormone Therapy)
- Prednisone (Hormone Therapy)
- Radiation Therapy (Radiation)
- Triptorelin (Hormone Therapy)
Abiraterone Acetate is already approved in Canada, Japan for the following indications:
- Metastatic castration-resistant prostate cancer
- Metastatic castration-sensitive prostate cancer
- Prostate cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
NRG Oncology
Lead Sponsor
Stephanie Gaillard
NRG Oncology
Chief Medical Officer
MD from Johns Hopkins University
Norman Wolmark
NRG Oncology
Chief Executive Officer since 2023
MD from Harvard Medical School
National Cancer Institute (NCI)
Collaborator
Dr. Douglas R. Lowy
National Cancer Institute (NCI)
Chief Executive Officer since 2023
MD from New York University School of Medicine
Dr. Monica Bertagnolli
National Cancer Institute (NCI)
Chief Medical Officer since 2022
MD from Harvard Medical School