Study on Adding Apalutamide to Usual Hormone and Radiation Therapy After Prostate Cancer Surgery

Sponsor: NRG Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04134260

Provider View

This clinical trial is exploring whether adding the drug apalutamide to the standard hormone and radiation therapy can improve outcomes for patients with prostate cancer that has spread to the lymph nodes after surgery.

Patient Parameters

Program Overview

This study is investigating if adding apalutamide, a drug that blocks male hormones, to the usual hormone and radiation therapy can help control prostate cancer better after surgery. The goal is to see if this combination can prevent the cancer from spreading and extend the time patients remain free of disease compared to the standard treatment alone.

Description

The main goal of this study is to compare how long patients live without their cancer spreading when treated with standard radiation and hormone therapy, versus when apalutamide is added to these treatments. Researchers will also look at patients' quality of life, overall survival, and any side effects from the treatments.

Patients will be randomly assigned to one of two groups:

  • Group 1: Will receive standard hormone therapy and radiation to the pelvis and prostate area for 5-8 weeks.
  • Group 2: Will receive the same standard treatment as Group 1, plus apalutamide taken daily for up to 8 cycles (each cycle lasts 90 days).

After finishing the treatment, patients will have follow-up visits every 6 months for 3 years, then once a year.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate cancer that has spread to lymph nodes.
  • Have had prostate surgery.
  • Any stage of prostate cancer is eligible.
  • Recent PET scan showing no distant cancer spread.
  • Cancer cells found in pelvic lymph nodes.
  • Good overall health with an ECOG score of 0 or 1.
  • Detectable PSA levels after surgery.
  • Started hormone therapy within 180 days before joining the study.
  • Meet specific blood test requirements.
  • Agree to use effective birth control during the study.
  • HIV-positive patients can join if their viral load is undetectable.
  • Hepatitis B or C patients can join if their viral load is undetectable.
  • No other cancers that could interfere with the study.

Exclusion Criteria

  • Evidence of cancer spread beyond the pelvis.
  • Previous chemotherapy for prostate cancer.
  • Previous radiation that overlaps with study treatment.
  • Hormone therapy before prostate surgery.
  • Use of certain medications that affect hormone levels.
  • History of seizures or conditions that increase seizure risk.
  • Recent severe heart problems.
  • Uncontrolled high blood pressure.
  • Severe liver problems.
  • Inability to swallow pills.
  • Planning to join another clinical trial during this study.
  • Inflammatory bowel disease.

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