Trial Title:
Hormone Therapy (Apalutamide) and Image-guided Stereotactic Body Radiation Therapy for the Treatment of Patients with Prostate Cancer, HEATWAVE Trial
NCT ID:
NCT06067269
Condition:
Prostate Adenocarcinoma
Stage II Prostate Cancer AJCC V8
Stage IIIA Prostate Cancer AJCC V8
Stage IIIB Prostate Cancer AJCC V8
Conditions: Official terms:
Prostatic Neoplasms
Edetic Acid
Gallium 68 PSMA-11
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Apalutamide
Description:
Given PO
Arm group label:
Treatment (apalutamide, SBRT)
Other name:
ARN 509
Other name:
ARN-509
Other name:
ARN509
Other name:
Erleada
Other name:
JNJ 56021927
Other name:
JNJ-56021927
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood samples
Arm group label:
Treatment (apalutamide, SBRT)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo PSMA-PET/CT
Arm group label:
Treatment (apalutamide, SBRT)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Other
Intervention name:
Gallium Ga 68 Gozetotide
Description:
Undergo PSMA-PET/CT
Arm group label:
Treatment (apalutamide, SBRT)
Other name:
(68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
Other name:
(68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC
Other name:
(68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
Other name:
(68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
Other name:
(68Ga)Glu-urea-Lys(Ahx)-HBED-CC
Other name:
68Ga-DKFZ-PSMA-11
Other name:
68Ga-HBED-CC-PSMA
Other name:
68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
Other name:
68Ga-PSMA
Other name:
68Ga-PSMA-11
Other name:
68Ga-PSMA-HBED-CC
Other name:
[68Ga] Prostate-specific Membrane Antigen 11
Other name:
[68Ga]GaPSMA-11
Other name:
AAA 517
Other name:
AAA-517
Other name:
AAA517
Other name:
Ga PSMA
Other name:
Ga-68 labeled DKFZ-PSMA-11
Other name:
Ga-68 labeled PSMA-11
Other name:
GA-68 PSMA-11
Other name:
Gallium Ga 68 PSMA-11
Other name:
Gallium Ga 68-labeled PSMA-11
Other name:
GALLIUM GA-68 GOZETOTIDE
Other name:
Gallium-68 PSMA
Other name:
Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
Other name:
GaPSMA
Other name:
PSMA-HBED-CC GA-68
Intervention type:
Radiation
Intervention name:
Guided Stereotactic Body Radiation Therapy
Description:
Undergo guided SBRT
Arm group label:
Treatment (apalutamide, SBRT)
Intervention type:
Procedure
Intervention name:
Multiparametric Magnetic Resonance Imaging
Description:
Undergo multiparametric MRI
Arm group label:
Treatment (apalutamide, SBRT)
Other name:
MP-MRI
Other name:
mpMRI
Other name:
Multi-parametric MRI
Other name:
Multiparametric MRI
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PSMA-PET/CT
Arm group label:
Treatment (apalutamide, SBRT)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron emission tomography (procedure)
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Treatment (apalutamide, SBRT)
Summary:
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.
Detailed description:
PRIMARY OBJECTIVE:
I. 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.
SECONDARY OBJECTIVES:
I. Assessing time to biochemical recurrence (BCR; PSA ≥ nadir PSA + 2 ng/mL) among
patients initially meeting primary endpoint.
II. 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.
III. Assessing patient-reported bowel quality of life, as assessed by the EPIC-26 survey
instrument 24 months after radiotherapy completion.
IV. 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.
V. Assessing radiographic persistence of disease on a multiparametric MRI at fixed
intervals (i.e., 6, 12, 18, 24, 30) months after radiotherapy completion.
VI. Assessment of longitudinal changes in patient-reported quality of life metrics on the
EPIC-26 survey instrument.
VII. Physician-reported acute and late toxicities as per the Common Terminology Criteria
for Adverse Events (CTCAE) scale version (v)5.0.
OUTLINE:
Patients receive apalutamide orally (PO) once daily (QD) on days 1-28 of each cycle.
Cycles repeat every 28 days for up to 6 or 12 months in the absence of disease
progression or unacceptable toxicity. Patients undergo SBRT for 5 fractions over 1-2
weeks beginning on day 1 of cycle 1. Patients also undergo multiparametric MRI and
collection of blood samples throughout the trial. Patients undergo PSMA-PET/CT scans
during screening and follow up.
After completion of study treatment, patients are followed up every 3 months for up to 24
months after SBRT and then up to 60 months after SBRT.
Criteria for 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)
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCLA / Jonsson Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Contact:
Last name:
Maria Casado
Phone:
310-794-6913
Email:
Casado@mednet.ucla.edu
Contact backup:
Last name:
Amar Kishan
Start date:
March 28, 2024
Completion date:
December 1, 2027
Lead sponsor:
Agency:
Jonsson Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
Janssen Scientific Affairs, LLC
Agency class:
Industry
Source:
Jonsson Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06067269
