Antiandrogen Therapy and SBRT in Treating Patients With Recurrent, Metastatic Prostate Cancer

NCT03902951 | Active Not Recruiting Phase 2 DMC FDA Drug FDA Device

• 2 other identifiers: 18-001037NCI-2019-00337
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well antiandrogen therapy (leuprolide, apalutamide, and abiraterone acetate) and stereotactic body radiation therapy (SBRT) works in treating patients with prostate cancer that has come back and has spread to other parts of the body. Drugs used in chemotherapy, such as leuprolide, apalutamide, and abiraterone acetate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving antiandrogen therapy and SBRT may work better in treating patients with prostate cancer.

Conditions

Metastatic Prostate Adenocarcinoma; Prostate Adenocarcinoma With Focal Neuroendocrine Differentiation; Recurrent Prostate Carcinoma; Stage IVB Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Percent of patients achieving a serum prostate specific antigen (PSA) of < 0.05 ng/mL

  Will be summarized by count and percent along with the 95% confidence interval.

  Up to 6 months post treatment

Secondary Outcomes (7)

• Time to biochemical progression

  Baseline to first rise in PSA to 0.2 ng/mL, assessed up to 2 years

• Time to radiographic progression

  Baseline to time when any imaging shows new evidence of metastatic disease, assessed up to 2 years

• Time to initiation of alternative antineoplastic therapy

  Baseline to time when new anti-prostate cancer therapy is initiated, assessed up to 2 years

• Prostate cancer specific survival

  Up to 2 years post treatment

• Health related quality of life: Functional Assessment of Cancer Therapy - Prostate (FACT-P) scale - patient questionnaire

  Up to 2 years post treatment

Other Outcomes (4)

• Genomic and transcriptomic features present in metastatic tumors

  Up to 2 years post treatment

• Circulating tumor deoxyribonucleic acid (ctDNA) for predictors of response

  Up to 2 years post treatment

• Circulating tumor cells (CTCs) for predictors of response

  Up to 2 years post treatment

Study Arms (1)

Treatment (leuprolide, apalutamide, abiraterone acetate, SBRT)

EXPERIMENTAL

Patients receive leuprolide SC on day 1, Patients receive a single dose of leuprolide SC on day 1 and apalutamide PO QD and abiraterone acetate PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. Beginning 2 months of initiation of ADT, patients also receive SBRT over 1, 3, or 5 fractions in the absence of disease progression or unacceptable toxicity.

Drug: Abiraterone Acetate; Drug: Apalutamide; Drug: Leuprolide Acetate; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Body Radiation Therapy

Interventions

Leuprolide Acetate DRUG

Given SC

Also known as: A-43818, Abbott 43818, Abbott-43818, Carcinil, Depo-Eligard, Eligard, Enanton, Enantone, Enantone-Gyn, Ginecrin, LEUP, Leuplin, Leuprorelin Acetate, Lucrin, Lucrin Depot, Lupron, Lupron Depot, Lupron Depot-3 Month, Lupron Depot-4 Month, Lupron Depot-Ped, Procren, Procrin, Prostap, TAP-144, Trenantone, Uno-Enantone, Viadur

Treatment (leuprolide, apalutamide, abiraterone acetate, SBRT)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (leuprolide, apalutamide, abiraterone acetate, SBRT)

Questionnaire Administration OTHER

Ancillary studies

Treatment (leuprolide, apalutamide, abiraterone acetate, SBRT)

Stereotactic Body Radiation Therapy RADIATION

Undergo SBRT

Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

Treatment (leuprolide, apalutamide, abiraterone acetate, SBRT)

Abiraterone Acetate DRUG

Given PO

Also known as: CB7630, Zytiga

Treatment (leuprolide, apalutamide, abiraterone acetate, SBRT)

Apalutamide DRUG

Given PO

Also known as: ARN 509, ARN-509, ARN509, JNJ 56021927, JNJ-56021927

Treatment (leuprolide, apalutamide, abiraterone acetate, SBRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of prostate adenocarcinoma after radical prostatectomy (primary small cell carcinoma of the prostate is not allowed, however adenocarcinoma with neuroendocrine differentiation is allowed)
• Presence of 1-5 visible metastases (by PSMA PET-CT)
• At least one metastasis must be M1a-b
• Visceral metastases are not allowed
• Patients may have any number of pelvic nodal metastases (but largest must be \< 2 cm)
• Metastases must be amenable to treatment with SBRT
• Biopsy of one metastasis must be attempted, unless unsafe to perform
• Patient must be fit to undergo SBRT to all visible sites of metastases, ADT
• Total testosterone \> 150 ng/dL prior to ADT (optimal time to measure total testosterone is between 8 and 9 am)
• 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
• Platelet count \>= 100,000 x 10\^9/uL independent of transfusion and/or growth factors within 3 months prior to randomization
• Serum albumin \>= 3.0 g/dL
• Glomerular filtration rate (GFR) \>= 45 mL/min
• Serum potassium \>= 3.5 mmol/L

You may not qualify if:

• Any evidence of spinal cord compression (radiological or clinical)
• Prior pelvic malignancy
• Prior pelvic radiation aside from salvage prostate radiation
• Concurrent malignancy aside from superficial skin cancers or superficial bladder tumors
• Inability to undergo radiotherapy, or ADT
• 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
• Active infection (eg, human immunodeficiency virus \[HIV\] or viral hepatitis)
• Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone once daily

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Janssen Inc.: collaborator

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Nikitas J, Rettig M, Shen J, Reiter R, Lee A, Steinberg ML, Valle LF, Sachdeva A, Romero T, Calais J, Czernin J, Nickols NG, Kishan AU. Systemic and Tumor-directed Therapy for Oligorecurrent Metastatic Prostate Cancer (SATURN): Primary Endpoint Results from a Phase 2 Clinical Trial. Eur Urol. 2024 Jun;85(6):517-520. doi: 10.1016/j.eururo.2024.01.021. Epub 2024 Mar 16.

  PMID: 38494380 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate; apalutamide; Leuprolide; luprolide acetate gel depot; Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Amar Kishan

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 4, 2019
• Study Start: March 17, 2021
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (1)