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Newly Diagnosed Oligometastatic Prostate CancerPhase 2NCT03298087

Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer

A Phase 2 study testing radical prostatectomy, stereotactic body radiotherapy and Leuprolide in people with Newly Diagnosed Oligometastatic Prostate Cancer, run by VA Office of Research and Development at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
radical prostatectomy, stereotactic body radiotherapy and Leuprolide
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
3 sitesUnited States
Study dates
1 Jul 2018to 31 Mar 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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
  • GFR 45 mL/min
  • Serum potassium 3.5 mmol/L
  • Serum total bilirubin 1.5 ULN (Note: In subjects with Gilbert's syndrome, if total bilirubin is >1.5 ULN, measure direct and indirect bilirubin and if direct bilirubin is 1.5 ULN, subject may be eligible)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5 ULN
  • 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.

Who cannot join

  • 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)
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  • 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
  • Any condition that in the opinion of the investigator would preclude participation in this study
  • Concomitant strong CYP3A4 inducers. (If a strong CYP3A4 inducer must be co-administered, abiraterone acetate dose frequency will be adjusted).
  • 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 severe hepatic impairment (ChildPugh Class B \& C)
  • Presence of visceral metastases (i.e., stage M1c)

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • VA Long Beach Healthcare System, Long Beach, CA

    Long Beach, California, 90822

  • Hunter Holmes McGuire VA Medical Center, Richmond, VA

    Richmond, Virginia, 23249

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

    West Los Angeles, California, 90073-1003

Other trials in United States

About this study

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.

Read the detailed description

This is a single arm Phase II clinical trial in patients with newly diagnosed M1a,b prostate cancer and 1-5 radiographically visible metastases treated with radical prostatectomy (and post-operative fractionated radiotherapy for pT 3a, pN1, or positive margins) or radiation to the prostate, 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. The primary endpoint of our study is the percent of patients achieving a serum PSA of <0.05 ng/mL six months after recovery of serum testosterone (for patients undergoing radical prostatectomy) or PSA <nadir+2 (for patients undergoing prostate radiation).

Being tested
radical prostatectomy, stereotactic body radiotherapy, Leuprolide, apalutamide, abiraterone
Keywords
oligometastatic, SBRT, abiraterone, apalutamide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • radical prostatectomyProcedure or surgery

    surgical removal of the prostate

  • stereotactic body radiotherapyRadiation

    Also called SBRT

    Highly targeted radiation

  • LeuprolideDrug

    Also called ADT

    Lowers serum testosterone

  • apalutamideDrug

    Also called ARN-509

    antiandrogen

  • abirateroneDrug

    Also called zytiga

    Inhibits androgen synthesis

Study groups in NCT03298087
Study groupRoleWhat they receive
Experimental ArmExperimentalRadical 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.
Receives: Procedure: radical prostatectomy; Radiation: stereotactic body radiotherapy; Drug: Leuprolide; Drug: apalutamide; Drug: abiraterone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months after recovery of testosterone

Secondary outcomes (6)

  1. Time to Biochemical Progression

    biochemical, radiographic, or clinical

    Measured: up to 5 years

  2. Time to Radiographic Progression

    per PCWG3 criteria

    Measured: up to 5 years

  3. Time to Initiation of Additional Antineoplastic Therapy

    antineoplastic therapy includes any systemic or focal anti-prostate cancer therapy

    Measured: up to 5 years

  4. Prostate Cancer Specific Survival

    Prostate cancer specific survival

    Measured: up to 5 years

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

    This uses the Functional Assessment of Cancer Therapy - Prostate (FACT-P) questionnaire. It assesses patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Items are rated on a 0 to 4 Likert type scale and combined to produce sub-scores that are summed into a total FACT-P score, the higher the score, the better the quality of life. Range from 0-150 . Data was aggregated per patient and over time. Data represented here are the mean scores and 95% confidence intervals of the participants who filled out the questionnaire (15/24 completed through 18 months, 12/24 completed through 21 months).

    Measured: Every 3 months up to a total of 21 months

  6. Number of Participants With Treatment-related Adverse Events as Assessed by Physician Using CTCAE v4.0 Criteria

    CTCAE v4 criteria are a set of criteria for the standardized classification of adverse effects cancer therapy. The CTCAE system is a product of the US National Cancer Institute. The criteria are assessed by physician. The grades range from 0 to 5 (higher is worse). Data will be aggregated per patient and over time and classified by organ system (e.g., genitourinary, gastrointestinal, etc).

    Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2017
  2. Study start1 Jul 2018
  3. Primary completion31 Mar 2024
  4. Study completion31 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single arm Phase II clinical trial
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03298087
Sponsor's protocol ID
ONCA-013-16F
Status last verified
Jul 2025
First submitted
26 Sep 2017
Last updated
1 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30935383

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing radical prostatectomy, stereotactic body radiotherapy and Leuprolide in people with Newly Diagnosed Oligometastatic Prostate Cancer, run by VA Office of Research and Development at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With PSA<0.05ng/mL (Radical Prostatectomy) or PSA <Nadir+2ng/mL (Prostate Radiation) (time frame: 6 months after recovery of testosterone). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03298087, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.

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