Hormone therapy and targeted radiation for prostate cancer treatment
High Precision Stereotactic Radiotherapy to the Whole Prostate With Focal Boost and Varying Hormonal Therapy (HEATWAVE)
This study is testing if combining a hormone therapy that blocks testosterone with targeted radiation can help men with prostate cancer see better results and improve their quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 95 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Jonsson Comprehensive Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06067269 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the effectiveness of apalutamide, a hormone therapy that blocks testosterone's effects on prostate tumor cells, in combination with image-guided stereotactic body radiation therapy (SBRT) for patients with prostate cancer. The study aims to assess the complete response rates of prostate specific antigen (PSA) in patients with unfavorable intermediate risk prostate cancer. It also evaluates secondary outcomes such as time to biochemical recurrence, patient-reported quality of life, and radiographic persistence of disease using advanced imaging techniques. The trial utilizes precision dose-escalation and de-escalation methods to optimize treatment delivery.
Who should consider this trial
Good fit: Ideal candidates include adult males aged 18 and older with confirmed unfavorable intermediate risk prostate adenocarcinoma and specific imaging and genomic criteria.
Not a fit: Patients with low-risk prostate cancer or those who do not meet the specific inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with prostate cancer by enhancing PSA response rates and minimizing side effects.
How similar studies have performed: Other studies have shown promising results with similar combinations of hormone therapy and targeted radiation, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed diagnosis of prostate adenocarcinoma * Age ≥ 18 * Classified as having National Comprehensive Cancer Network unfavorable intermediate risk prostate cancer (i.e., \[a\] 2 of the following: PSA 10-20 ng/mL, clinical T category 2b-2c, or International Society of Urological Pathology \[ISUP\] grade group 2; \[b\] OR any 1 of \[a\] with ISUP grade group 3 disease; OR \[c\] any 1 of \[a\] with 50% or more cores on systematic biopsy showing prostate cancer) * Have a Decipher genomic classifier score * Have at least one dominant intraprostatic lesion visible on multiparametric MRI (Prostate Imaging-Reporting and Data System \[PI-RADS\] version 2.1 score 4 or 5) * Have underwent a prostate specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) * Have total testosterone \>= 150 ng/dL * Adequate performance status (Eastern Cooperative Oncology Group \[ECOG\] 0-1) * 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) * Medications known to lower the seizure threshold (see list under prohibited medications) must be discontinued or substituted at least 4 weeks prior to study entry Exclusion Criteria: * Any evidence of spinal cord compression (radiological or clinical) * Prior pelvic malignancy * Prior pelvic radiation * Concurrent malignancy other than adequately treated basal cell or squamous cell skin cancer, non-muscle invasive bladder cancer (NMIBC), or any other cancer in situ currently without evidence of recurrence or progression * Inability to undergo radiotherapy, or hormonal therapy * Primary small cell carcinoma of the prostate (prostate adenocarcinoma with neuroendocrine differentiation is allowed) * Inflammatory bowel disease or active collagen vascular disease * History of any of the following: * Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system \[CNS\] or meningeal disease which may require treatment with surgery or radiation therapy) * Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization * Current evidence of any of the following: * Uncontrolled hypertension * Gastrointestinal disorder affecting absorption * Known active infection (eg, human immunodeficiency virus \[HIV\] or viral hepatitis) * Any condition that in the opinion of the investigator would preclude participation in this study * Treatment with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, a dose reduction of the CYP2D6 substrate may be considered * Baseline moderate and severe hepatic impairment (Child Pugh class B \& C)
Where this trial is running
Los Angeles, California
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Amar Kishan — UCLA / Jonsson Comprehensive Cancer Center
- Study coordinator: Christy Palodichuk
- Email: cpalodichuk@mednet.ucla.edu
- Phone: 310-267-8988
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.