Recruiting
Phase 2

Apalutamide & SBRT

Sponsor:

Jonsson Comprehensive Cancer Center

Code:

NCT06067269

Conditions

Prostate Adenocarcinoma

Stage II Prostate Cancer AJCC v8

Stage IIIA Prostate Cancer AJCC v8

Stage IIIB Prostate Cancer AJCC v8

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Apalutamide

Biospecimen Collection

Computed Tomography

Gallium Ga 68 Gozetotide

Guided Stereotactic Body Radiation Therapy

Study Details

Brief 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.

Conditions

Prostate Adenocarcinoma

Stage II Prostate Cancer AJCC v8

Stage IIIA Prostate Cancer AJCC v8

Stage IIIB Prostate Cancer AJCC v8

Study ID

NCT06067269

Start date

Mar 28, 2024

Status verified date

Jul, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

95 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (apalutamide, SBRT)

Patients receive apalutamide PO 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.

Interventions

Apalutamide

Given PO

Biospecimen Collection

Undergo collection of blood samples

Computed Tomography

Undergo PSMA-PET/CT

Gallium Ga 68 Gozetotide

Undergo PSMA-PET/CT

Guided Stereotactic Body Radiation Therapy

Undergo guided SBRT

Multiparametric Magnetic Resonance Imaging

Undergo multiparametric MRI

Positron Emission Tomography

Undergo PSMA-PET/CT

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Percent of patients achieving prostate specific antigen (PSA) of < 0.2 ng/mL [ Time Frame: Three months after completion of apalutamide ]

Central Contacts and Locations

Central contacts

Christy Palodichuk

310-267-8988cpalodichuk@mednet.ucla.edu

Locations

UCLA / Jonsson Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Maria Casado

310-794-6913Casado@mednet.ucla.edu

Principal Investigator:

Amar Kishan

More Information

Sponsor

Jonsson Comprehensive Cancer Center

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center on 2026-07-17.