Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging
Phase 3
804
about 12 years
18+
Male only
303 sites in AK, AR, AZ +29
What this study is about
This trial is testing whether adding apalutamide to standard prostate cancer treatment, along with targeted radiation based on PET scans for those whose cancer has spread outside the pelvis, improves outcomes compared to standard treatment alone. It involves men with prostate cancer that has returned after surgery and who have evidence of cancer spreading beyond the pelvic area.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Fluciclovine F18
- 2.Quality-of-Life Assessment
- 3.Questionnaire Administration
- +3 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You are randomly assigned, but you will know your treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
apalutamide, degarelix, Diagnostic Agent (Positron Emitting Activity), Antineoplastic Agent [TC] (Gonadotropin Releasing Hormone Receptor Agonists), relugolix, triptorelin
oral (Oral Tablet), injection (Injection), injection, intramuscular
Primary: PFS prolongation in patients with PET-evidence of extrapelvic metastases, PFS prolongation in patients without PET-evidence of extrapelvic metastases, Progression-free survival (PFS), Quality of life (QOL)
Secondary: Change in FACT-P and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, Concordance of detection rate with the follow-up conventional imaging modalities (CIM), Event-free survival, Incidence of adverse events, Overall survival (OS), QOL Assessments at Progression
imaging, radiation