Treating Prostate Cancer That Has Returned After Surgery with Apalutamide and Targeted Radiation Based on PET Imaging

Sponsor: ECOG-ACRIN Cancer Research Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04423211

Provider View

This study is exploring whether adding the drug apalutamide and targeted radiation therapy to standard treatment can better control prostate cancer that has returned after surgery. The trial also examines if these additions help when cancer has spread outside the pelvis, as shown by PET scans.

Patient Parameters

Program Overview

This phase III trial is investigating two main questions. First, it looks at whether adding apalutamide and other medications to standard prostate cancer treatment (radiation and hormone therapy) is more effective for patients whose cancer has returned after surgery. Second, it examines if adding targeted radiation therapy to these enhanced treatments helps patients whose cancer has spread outside the pelvis, as detected by PET scans. PET imaging helps doctors find cancer that has spread. Apalutamide works by blocking hormones that can promote cancer growth. This study aims to see if these additional treatments can improve outcomes for patients with recurring prostate cancer.

Description

The study has several goals. For patients without cancer spread outside the pelvis, it aims to see if adding enhanced therapy to standard radiation can delay cancer progression. For those with cancer spread outside the pelvis, it evaluates if adding targeted radiation to enhanced therapy can also delay progression. The study will compare quality of life between different treatment groups and assess overall survival, time to cancer progression, and side effects. It will also explore how well PET scans detect cancer spread and how they compare to other imaging methods. Participants will undergo PET scans and be assigned to one of four treatment groups based on their scan results. Treatments include standard radiation, hormone therapy, and possibly apalutamide and targeted radiation. After treatment, patients will have regular follow-ups to monitor their health and cancer status.

Eligibility Criteria

Inclusion Criteria

  • Must be male and 18 years or older.
  • Must have had surgery to remove prostate cancer and now have a rising PSA level, indicating cancer recurrence.
  • Must not have cancer spread outside the pelvis as shown by standard imaging tests.
  • Must be eligible for radiation therapy to the prostate area and pelvic nodes with hormone therapy.
  • Must be able to understand and sign a consent form.
  • Must have a good performance status, meaning they are fully active or have some restrictions but can still do light work.
  • Must not have started hormone therapy for cancer recurrence before the baseline PET scan.
  • Must not be in another clinical trial.
  • Must be able to lie still for PET scans and radiation treatment.
  • Must not have a history of seizures or conditions that could cause seizures.
  • Must not have inflammatory bowel disease or gastrointestinal disorders that could complicate radiation therapy.
  • Must have adequate blood counts and organ function as shown by recent lab tests.
  • Must not have had previous pelvic radiation therapy.
  • Must agree not to father children during the study.
  • Must speak English or Spanish for the quality of life part of the study.
  • Must have completed a baseline PET scan showing whether cancer has spread outside the pelvis.

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