Trials / Withdrawn

WithdrawnNCT04585932

Androgen Deprivation Therapy and Apalutamide With or Without Radiation Therapy for the Treatment of Biochemically Recurrent Prostate Cancer, RESTART Study

Phase 2 Response Evaluation of Finite Systemic Therapy With Advanced Androgen Signaling Inhibition and Radiation Therapy for Oligorecurrent Prostate Cancer (RESTART)

Status: Withdrawn
Phase: Phase 2
Study type: Interventional
Enrollment: 0 (actual)

Sponsor: M.D. Anderson Cancer Center · Academic / Other
Sex: Male
Age: 18 Years
Healthy volunteers: Not accepted

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.

Conditions

Interventions

Type	Name	Description
DRUG	Apalutamide	Given PO
DRUG	Degarelix	Given SC
DRUG	Leuprolide Acetate	Given IM
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
RADIATION	Radiation Therapy	Undergo RT

Timeline

Start date: 2020-11-24
Primary completion: 2021-01-08
Completion: 2021-01-08
First posted: 2020-10-14
Last updated: 2021-01-20

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04585932. Inclusion in this directory is not an endorsement.