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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT04585932
Phase
PHASE2
Status
Withdrawn

Conditions

  • Biochemically Recurrent Prostate Carcinoma
  • Metastatic Prostate Carcinoma
  • Oligometastatic Prostate Carcinoma
  • Stage IV Prostate Cancer AJCC v8
  • Stage IVA Prostate Cancer AJCC v8
  • Stage IVB Prostate Cancer AJCC v8

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 24, 2020
Status verified
Jan 2021
Primary completion
Jan 8, 2021
Completion
Jan 8, 2021

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group I (apalutamide, leuprolide, degarelix)
    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.
  • Experimental: Group II (apalutamide, leuprolide, degarelix, RT)
    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 RT between cycles 4-7 in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Time to prostate specific antigen (PSA) recurrence [ Time Frame: From treatment start with androgen deprivation therapy plus apalutamide until PSA recurrence (> 0.2 ng/ml) for patients who received surgery, or PSA >= nadir+2ng/mL for patients who received only prior definitive radiation of the prostate, up to 4 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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By research site
M D Anderson Cancer Center· Houston, TX

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