This phase II trial compares external beam radiation therapy plus short-term (6 months) androgen deprivation therapy (ADT) with optional androgen receptor pathway inhibitor therapy (ARPI) to external beam radiation therapy plus long-term (18 months) ADT for the treatment of prostate cancer that has not spread to other parts of the body (localized). External beam radiation therapy is a type of radiation therapy that uses a machine to aim high-energy rays at the cancer from outside of the body to kill tumor cells and shrink tumors. Testosterone can cause the growth of prostate cancer cells. ADT and ARPI lower the amount of testosterone made by the body. This may help stop the growth of tumor cells that need testosterone to grow. ARPI is usually given with another drug called a corticosteroid to lower the body's immune response and lessen the side effects of ARPI. Researchers think that external beam radiation therapy plus short-term ADT with optional ARPI may be as effective or more effective than external beam radiation therapy plus long-term ADT in treating localized prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07364071.
Locations matching your search criteria
United States
California
La Jolla
UC San Diego Moores Cancer CenterStatus: Active
Contact: Tyler M Seibert
Phone: 858-246-5988
PRIMARY OBJECTIVE:
I. To compare failure-free survival (FFS) of radiotherapy plus short-term ADT/optional ARPI to that of radiotherapy plus long-term ADT in patients with high-risk, localized prostate cancer.
SECONDARY OBJECTIVE:
I. To compare additional oncologic outcomes of radiotherapy plus short-term ADT/optional ARPI to those of radiotherapy plus long-term ADT.
TERTIARY/EXPLORATORY OBJECTIVE:
I. To investigate prognostic biomarkers and biomarkers predictive of benefit to treatment.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo photon or proton external beam radiation therapy as per standard treatment schedule and receive ADT as per clinical standard practice for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients may also receive ARPI plus corticosteroid as clinically indicated at the discretion of the treating physician on study. Additionally, patients undergo blood sample collection as well as magnetic resonance imaging (MRI) and prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) throughout the trial.
ARM II: Patients undergo photon or proton external beam radiation therapy as per standard treatment schedule and receive ADT as per clinical standard practice for up to 18 months in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection as well as MRI and PSMA PET/CT throughout the trial.
After completion of study treatment, patients are followed up every 3 months for up to 5 years from the completion of radiation therapy.
Lead OrganizationUC San Diego Moores Cancer Center
Principal InvestigatorTyler M Seibert
