OncoMatch/Clinical Trials/NCT04423211
Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging
Is NCT04423211 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for biochemically recurrent prostate carcinoma.
Treatment: Apalutamide · Degarelix · Goserelin Acetate · Leuprolide Acetate · Relugolix · Triptorelin — This phase III trial tests two questions by two separate comparisons of therapies. The first question is whether enhanced therapy (apalutamide in combination with abiraterone + prednisone) added to standard of care (prostate radiation therapy and short term androgen deprivation) is more effective compared to standard of care alone in patients with prostate cancer who experience biochemical recurrence (a rise in the blood level of prostate specific antigen \[PSA\] after surgical removal of the prostate cancer). A second question tests treatment in patients with biochemical recurrence who show prostate cancer spreading outside the pelvis (metastasis) by positron emission tomography (PET) imaging. In these patients, the benefit of adding metastasis-directed radiation to enhanced therapy (apalutamide in combination with abiraterone + prednisone) is tested. Diagnostic procedures, such as PET, may help doctors look for cancer that has spread to the pelvis. Androgens are hormones that may cause the growth of prostate cancer cells. Apalutamide may help fight prostate cancer by blocking the use of androgens by the tumor cells. Metastasis-directed targeted radiation therapy uses high energy rays to kill tumor cells and shrink tumors that have spread. This trial may help doctors determine if using PET results to deliver more tailored treatment (i.e., adding apalutamide, with or without targeted radiation therapy, to standard of care treatment) works better than standard of care treatment alone in patients with biochemical recurrence of prostate cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage IVB (AJCC v8)
Stage IVB Prostate Cancer AJCC v8
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: radical prostatectomy — definitive
Patient must have had a radical prostatectomy (RP) as definitive therapy for histopathologically-proven prostatic adenocarcinoma
Cannot have received: androgen deprivation therapy
Exception: A short course of low-dose anti-androgen such as bicalutamide, given after baseline study PET/CT but prior to study registration, is permitted as a brief temporizing measure in advance of starting protocol-approved SOC ADT.
Patient must not have started ADT for biochemical recurrence prior to baseline PET (PET1) imaging.
Cannot have received: pelvic radiation therapy
Patient must not have completed a course of prior pelvic radiation therapy for any reason
Lab requirements
Blood counts
Hemoglobin (Hgb) >= 9.0 g/dL (independent of transfusion and/or growth factors within 3 months prior to Step 0 registration); Leukocytes >= 3,000/mcL; Absolute neutrophil count >= 1,500/mcL; Platelets >= 100,000/mcL
Kidney function
Creatine < 1.5 x institutional ULN (or measured creatinine clearance > 30 mL/min)
Liver function
Total bilirubin < 1.5 x institutional upper limit of normal (ULN) (patients with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, must have a direct bilirubin of < 1.5 x ULN to be eligible); AST/ALT <= 2.5 x institutional ULN
Cardiac function
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class I or II (by patient symptoms) or A or B (by objective assessment)
Hemoglobin (Hgb) >= 9.0 g/dL...Leukocytes >= 3,000/mcL...Absolute neutrophil count >= 1,500/mcL...Platelets >= 100,000/mcL...Total bilirubin < 1.5 x institutional upper limit of normal (ULN)...AST/ALT <= 2.5 x institutional ULN...Creatine < 1.5 x instituional ULN (or measured creatinine clearance > 30 mL/min)...cardiac risk assessment: NYHA class I/II or A/B
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Anchorage Associates in Radiation Medicine · Anchorage, Alaska
- Alaska Breast Care and Surgery LLC · Anchorage, Alaska
- Alaska Oncology and Hematology LLC · Anchorage, Alaska
- Alaska Women's Cancer Care · Anchorage, Alaska
- Anchorage Oncology Centre · Anchorage, Alaska
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