Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT04585932
Brief Summary:
This phase II trial studies how well androgen deprivation therapy and apalutamide with or without radiation therapy works for the treatment of prostate cancer that has a rise in the blood level of prostate-specific antigen (PSA) and has come back after treatment with surgery or radiation (biochemically recurrent). Androgens can cause the growth of prostate tumor cells. Apalutamide may help fight prostate cancer by blocking the use of androgens by the tumor cells. Androgen deprivation therapy drugs, leuprolide or degarelix, work to lower the amount of androgen in the body, also preventing the tumor cells from growing. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy with apalutamide and androgen deprivation therapy may help to control prostate cancer that has come back in only a few (up to 5) spots in the body.
Detailed Description:
PRIMARY OBJECTIVE:
I. To assess PSA progression-free survival in both treatment arms.
SECONDARY OBJECTIVES:
I. To assess time of recovery of serum testosterone in both treatment arms. II. To assess PSA progression-free survival and overall survival following testosterone recovery in both treatment arms.
III. To assess safety of androgen deprivation therapy (ADT) + apalutamide as well as ADT + apalutamide in combination radiation therapy.
IV. To assess the time to first new metastasis or local / pelvic recurrence in both treatment arms.
V. To assess the impact of both treatment arms on quality of life. VI. To assess the impact of both treatment arms on metabolic syndrome parameters.
VII. To assess the impact of both treatment arms on bone density. VIII. To investigate the association of changes in repeat advanced imaging with outcome.
IX. To compare fluciclovine and prostate specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT).
EXPLORATORY OBJECTIVE:
I. To identify potential markers of response or resistance to the administered therapies.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive apalutamide orally (PO) once daily (QD) on days 1-28 and ADT consisting of leuprolide intramuscularly (IM) every 12 weeks or degarelix subcutaneously (SC) every 4 weeks. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.
GROUP II: Patients receive apalutamide PO QD on days 1-28 and ADT consisting of leuprolide IM every 12 weeks or degarelix SC every 4 weeks. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy (RT) between cycles 4-7 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 and 4 months.
Study:
NCT04585932
Study Brief:
Protocol Section:
NCT04585932