Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer

NCT03298087 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: ONCA-013-16F
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

Brief Summary

This is a trial for patients with newly diagnosed metastatic prostate cancer with 5 or fewer sites of metastases. The trial involves surgery (removal of the prostate) or radiation to the prostate, six months of hormone therapy, and stereotactic body radiotherapy to the sites of metastasis.

Conditions

Newly Diagnosed Oligometastatic Prostate Cancer

Keywords

oligometastatic; SBRT; abiraterone; apalutamide

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With PSA<0.05ng/mL (Radical Prostatectomy) or PSA <Nadir+2ng/mL (Prostate Radiation)

  PSA is a biomarker for disease burden in prostate adenocarcinoma and offers a non-invasive and sensitive assessment of disease control after treatment in the vast majority of patients.

  6 months after recovery of testosterone

Secondary Outcomes (6)

• Time to Biochemical Progression

  up to 5 years

• Time to Radiographic Progression

  up to 5 years

• Time to Initiation of Additional Antineoplastic Therapy

  up to 5 years

• Prostate Cancer Specific Survival

  up to 5 years

• Patient Reported Outcomes as Assessed by Functional Assessment of Cancer Therapy - Prostate (FACT-P) Scale - Patient Questionnaire

  Every 3 months up to a total of 21 months

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Radical prostatectomy (and post-operative fractionated radiotherapy for pT=3a, pN1, or positive margins), metastasis directed SBRT, and complete ADT with LHRH analog leuprolide, abiraterone acetate with prednisone, and apalutamide (ARN-509) for a total of six months of systemic therapy.

Procedure: radical prostatectomy; Radiation: stereotactic body radiotherapy; Drug: Leuprolide; Drug: apalutamide; Drug: abiraterone

Interventions

radical prostatectomy PROCEDURE

surgical removal of the prostate

Experimental Arm

stereotactic body radiotherapy RADIATION

Highly targeted radiation

Also known as: SBRT

Experimental Arm

Leuprolide DRUG

Lowers serum testosterone

Also known as: ADT

Experimental Arm

apalutamide DRUG

antiandrogen

Also known as: ARN-509

Experimental Arm

abiraterone DRUG

Inhibits androgen synthesis

Also known as: zytiga

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Prostate cancer only affects males.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy confirmed diagnosis of prostate adenocarcinoma (primary small cell carcinoma of the prostate is not allowed, however adenocarcinoma with neuroendocrine differentiation is allowed)
• Age 18
• Presence of 1-5 visible metastases (by NaF PET-CT or PSMA PET-CT including diagnostic CT of the chest, abdomen, and pelvis)
• 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. If biopsy is not diagnostic, or unsafe to perform, then a secondary imaging modality (for example, MRI) must also be consistent with metastatic disease (unless PSMA PET-CT was used as initial staging).
• Patient must be fit to undergo radical prostatectomy, SBRT to all visible sites of metastases, ADT,
• Total testosterone \>200 ng/dL prior to ADT (optimal time to measure total testosterone is between 8 and 9 am)
• Adequate performance status (ECOG 0-1)
• Clinical laboratory values at screening:
• Hemoglobin 9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization
• Platelet count 100,000 x 109/ L independent of transfusion and/or growth factors within 3 months prior to randomization
• Serum albumin 3.0 g/dL

You may not qualify if:

• Any evidence of spinal cord compression (radiological or clinical)
• Prior pelvic malignancy
• Prior pelvic radiation
• Concurrent malignancy aside from superficial skin cancers or superficial bladder tumors
• Inability to undergo prostatectomy, 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 1year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign 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

• VA Office of Research and Development: lead

Study Sites (3)

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, 90822, United States

Location

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073-1003, United States

Location

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, 23249, United States

Location

Related Publications (1)

• Parikh NR, Huiza C, Patel JS, Tsai S, Kalpage N, Thein M, Pitcher S, Lee SP, Inouye WS, Jordan ML, Sanati H, Jafari L, Bennett CJ, Gin GE, Kishan AU, Reiter RE, Lewis M, Sadeghi A, Aronson WJ, Garraway IP, Rettig MB, Nickols NG. Systemic and tumor-directed therapy for oligometastatic prostate cancer: study protocol for a phase II trial for veterans with de novo oligometastatic disease. BMC Cancer. 2019 Apr 1;19(1):291. doi: 10.1186/s12885-019-5496-5.

  PMID: 30935383 DERIVED

MeSH Terms

Interventions

Radiosurgery; Leuprolide; apalutamide; abiraterone; Abiraterone Acetate

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; 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; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

Limitations include the moderate sample size and the lack of a control arm.

Results Point of Contact

• Title: Nathanael Kane
• Organization: West LA VAMC

nathanael.kane@va.gov

3104783711

Study Officials

• Nicholas George Nickols, MD PhD

  VA Greater Los Angeles Healthcare System, West Los Angeles, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Model Details: Single arm Phase II clinical trial

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: September 29, 2017
• Study Start: July 1, 2018
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: August 1, 2025
• Results First Posted: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)