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 (Jun 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
Treatments studied
Endocrine / hormonal
Cancer type
Prostate Cancer
Disease stage
Required: Stage II, IIIA, IIIB
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06067269 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior pelvic radiation, pelvic malignancy disqualifies patients from enrollment.
What disease stage is eligible?
Stage II or IIIA or IIIB is required.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages