RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 24 months, 60 months
  • Procedures mentioned: MRI scans, Questionnaires, CT scans, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "To assess prostate specific antigen (PSA) complete response rates in patients with unfavorable intermediate risk prostate cancer who are receiving apalutamide monotherapy in conjunction with magnetic resonance imaging stereotactic body radiotherapy with precision dose-escalation and de-escalation to involved and uninvolved areas of the prostate, respectively."
  • "Assessing patient-reported genitourinary quality of life, as assessed by the Expanded Prostate Cancer Index Composite-26 (EPIC-26) survey instrument 24 months after radiotherapy completion."
  • "Assessing patient-reported bowel quality of life, as assessed by the EPIC-26 survey instrument 24 months after radiotherapy completion."
  • "Assessing radiographic persistence of disease on a prostate specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) six months following hormonal therapy completion."
  • "Assessing radiographic persistence of disease on a multiparametric MRI at fixed intervals (i.e., 6, 12, 18, 24, 30) months after radiotherapy completion."
  • "Assessment of longitudinal changes in patient-reported quality of life metrics on the EPIC-26 survey instrument."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests apalutamide, a drug that blocks testosterone, with image-guided SBRT, which aims radiation precisely at cancer. It is for adults with prostate cancer in a group called unfavorable intermediate risk. Researchers want to see if this treatment lowers PSA, a blood marker for prostate cancer, to a very low level.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older with confirmed prostate adenocarcinoma, a type of prostate cancer.
  • Have unfavorable intermediate-risk cancer, based on PSA blood tests, cancer size or spread, and biopsy results.
  • Have a Decipher score, a test of the cancer’s genes.
  • Have at least one main tumor seen on a detailed prostate MRI, with a PI-RADS score of 4 or 5.
  • Have had a PSMA PET/CT scan, which looks for prostate cancer in the body.
  • Have testosterone of at least 150 ng/dL and be able to do most daily activities.
  • Meet study limits for blood counts, kidney and liver function, blood protein, and potassium. Blood counts must meet limits without recent transfusions or drugs that boost blood cells.
  • Stop or switch medicines that raise seizure risk at least 4 weeks before entering the study.

Who can't join

  • Have pressure on the spinal cord, a past cancer in the pelvis, or past radiation to the pelvis.
  • Have another current cancer, except certain treated skin cancers, bladder cancer that has not reached muscle, or cancer limited to its starting layer with no signs of return or growth.
  • Cannot receive radiation or hormone therapy, or have primary small cell prostate cancer. Adenocarcinoma with neuroendocrine features is allowed.
  • Have inflammatory bowel disease or an active disease that inflames connective tissue or blood vessels.
  • Have had a seizure or a condition that raises seizure risk, including a stroke within the past year or certain brain conditions.
  • Have had serious heart problems, blood clots, a stroke, or a mini-stroke within the past 6 months.
  • Have uncontrolled high blood pressure, trouble absorbing food or medicine, a known active infection, moderate or severe liver damage, or another condition the study doctor considers unsafe.
  • Take certain medicines processed by an enzyme called CYP2D6 that need very exact dosing. A different medicine or a lower dose may be considered.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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)

Study sites (1)

CA