Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE Trial

Conditions

• Prostate Adenocarcinoma
• Stage I Prostate Cancer AJCC v8
• Stage II Prostate Cancer AJCC v8
• Stage III Prostate Cancer AJCC v8
• Stage IVA Prostate Cancer AJCC v8

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Apalutamide — DRUG
  Given PO
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Bone Scan — PROCEDURE
  Undergo bone scan
• Computed Tomography — PROCEDURE
  Undergo CT
• Hormone Therapy — DRUG
  Receive hormone therapy
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Positron Emission Tomography — PROCEDURE
  Undergo PET
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies
• Radiation Therapy — RADIATION
  Undergo pelvis and prostate bed radiation therapy

Study Details

This phase III trial studies whether adding apalutamide to the usual treatment improves outcome in patients with lymph node positive prostate cancer after surgery. Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male sex hormones, can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may help stop or reduce the growth of prostate cancer cell growth by blocking the attachment of androgen to its receptors on cancer cells, a mechanism similar to stopping the entrance of a key into its lock. Adding apalutamide to the usual hormone therapy and radiation therapy after surgery may stabilize prostate cancer and prevent it from spreading and extend time without disease spreading compared to the usual approach.

Key Dates

Start date

Apr 16, 2020

Status verified

Jan 2026

Primary completion

Nov 1, 2026

Completion

Nov 1, 2026

Study Design

Enrollment

586 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (hormone therapy, radiation therapy)
  Patients receive standard of care hormone therapy per physician discretion for 24 months. Patients also undergo standard of care pelvis and prostate bed radiation therapy 5 days per week over 5-6 or 7-8 weeks beginning within 90 days of randomization in the absence of disease progression or unacceptable toxicity. Patients in both arms may undergo CT, MRI, bone scan, and PET as clinically indicated throughout the study. Patients may also undergo blood sample collection throughout the study.
• Experimental: Arm II (hormone therapy, radiation therapy, apalutamide)
  Patients undergo standard of care hormone therapy and radiation therapy as in Arm I. Patients also receive apalutamide PO QD on days 1-90 of each cycle. Cycles repeat every 90 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients in both arms may undergo CT, MRI, bone scan, and PET as clinically indicated throughout the study. Patients may also undergo blood sample collection throughout the study.

Primary Outcome Measure

Metastasis-free survival (MFS) [ Time Frame: From randomization to detection of metastatic disease or death from any cause, assessed up to 7.5 years ]

Locations (345)

Find similar trials in Phoenix, AZ

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