RECRUITING

Hormone Therapy (Apalutamide) and Image-guided Stereotactic Body Radiation Therapy for the Treatment of Patients with Prostate Cancer, HEATWAVE Trial

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Conditions

Prostate AdenocarcinomaStage II Prostate Cancer AJCC V8Stage IIIA Prostate Cancer AJCC V8Stage IIIB Prostate Cancer AJCC V8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

High Precision Stereotactic Radiotherapy to the Whole Prostate with Focal Boost and Varying Hormonal Therapy (HEATWAVE)

Quick Facts

Study Start:2024-03-28
Study Completion:2027-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06067269

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Confirmed diagnosis of prostate adenocarcinoma
  2. * Age ≥ 18
  3. * 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)
  4. * Have a Decipher genomic classifier score
  5. * 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)
  6. * Have underwent a prostate specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT)
  7. * Have total testosterone \>= 150 ng/dL
  8. * Adequate performance status (Eastern Cooperative Oncology Group \[ECOG\] 0-1)
  9. * Hemoglobin ≥ 9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization (at screening)
  10. * Platelet count ≥ 100,000 x 10\^9/uL independent of transfusion and/or growth factors within 3 months prior to randomization (at screening)
  11. * Serum albumin ≥ 3.0 g/dL (at screening)
  12. * Glomerular filtration rate (GFR) ≥ 45 mL/min (at screening)
  13. * Serum potassium ≥ 3.5 mmol/L (at screening)
  14. * 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)
  15. * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 2.5 x ULN (at screening)
  16. * 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
  1. * Any evidence of spinal cord compression (radiological or clinical)
  2. * Prior pelvic malignancy
  3. * Prior pelvic radiation
  4. * 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
  5. * Inability to undergo radiotherapy, or hormonal therapy
  6. * Primary small cell carcinoma of the prostate (prostate adenocarcinoma with neuroendocrine differentiation is allowed)
  7. * Inflammatory bowel disease or active collagen vascular disease
  8. * History of any of the following:
  9. * 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)
  10. * 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
  11. * Current evidence of any of the following:
  12. * Uncontrolled hypertension
  13. * Gastrointestinal disorder affecting absorption
  14. * Known active infection (eg, human immunodeficiency virus \[HIV\] or viral hepatitis)
  15. * Any condition that in the opinion of the investigator would preclude participation in this study
  16. * 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
  17. * Baseline moderate and severe hepatic impairment (Child Pugh class B \& C)

Contacts and Locations

Study Contact

Christy Palodichuk
CONTACT
310-267-8988
cpalodichuk@mednet.ucla.edu

Principal Investigator

Amar Kishan
PRINCIPAL_INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center

Study Locations (Sites)

UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: Jonsson Comprehensive Cancer Center

  • Amar Kishan, PRINCIPAL_INVESTIGATOR, UCLA / Jonsson Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-28
Study Completion Date2027-12-01

Study Record Updates

Study Start Date2024-03-28
Study Completion Date2027-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Prostate Adenocarcinoma
  • Stage II Prostate Cancer AJCC V8
  • Stage IIIA Prostate Cancer AJCC V8
  • Stage IIIB Prostate Cancer AJCC V8