OncoMatch/Clinical Trials/NCT06067269
Hormone Therapy (Apalutamide) and Image-guided Stereotactic Body Radiation Therapy for the Treatment of Patients With Prostate Cancer, HEATWAVE Trial
Is NCT06067269 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Apalutamide for prostate adenocarcinoma.
Treatment: Apalutamide — This phase II trial evaluates apalutamide in combination with image-guided stereotactic body radiation therapy (SBRT) for the treatment of patients with prostate cancer. Prostate cancer usually needs the hormone testosterone to grow. Apalutamide is a hormone therapy that blocks the effect of testosterone on prostate tumor cells. This may help stop the growth of tumor cells that need testosterone to grow. Image-guided SBRT is a standard treatment for some types of prostate cancer. This treatment combines imaging of cancer within the body, with the delivery of therapeutic radiation doses produced on a linear accelerator machine. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Combining apalutamide with image-guided SBRT may increase a prostate cancer patient's chances of achieving an extremely low prostate specific antigen response, which is an early predictor of disease cure.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage II, IIIA, IIIB
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: pelvic radiation
Prior pelvic radiation
Cannot have received: pelvic malignancy
Prior pelvic malignancy
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL, independent of transfusion/growth factors within 3 months; Platelet count ≥ 100,000 x 10^9/uL, independent of transfusion/growth factors within 3 months; Serum albumin ≥ 3.0 g/dL
Kidney function
Glomerular filtration rate (GFR) ≥ 45 mL/min
Liver function
Serum total bilirubin ≤ 1.5 x ULN (Gilbert's syndrome exception); AST or ALT < 2.5 x ULN; Baseline moderate and severe hepatic impairment (Child Pugh class B & C) excluded
Hemoglobin ≥ 9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization (at screening); Platelet count ≥ 100,000 x 10^9/uL independent of transfusion and/or growth factors within 3 months prior to randomization (at screening); Serum albumin ≥ 3.0 g/dL (at screening); Glomerular filtration rate (GFR) ≥ 45 mL/min (at screening); Serum potassium ≥ 3.5 mmol/L (at screening); Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible) (at screening); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 x ULN (at screening)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCLA / Jonsson Comprehensive Cancer Center · Los Angeles, California
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