A Phase 2 interventional study of radical prostatectomy and stereotactic body radiotherapy in Newly Diagnosed Oligometastatic Prostate Cancer, sponsored by VA Office of Research and Development. Completed at 3 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-01.
Sponsored by VA Office of Research and Development · Phase 2, Interventional, and Treatment
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.
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).
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 28 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Presence of 1-5 visible (by NaF PET-CT or PSMA PET-CT including diagnostic CT of the chest, abdomen, and pelvis)
Clinical laboratory values at screening:
Exclusion Criteria:
History of any of the following:
Current evidence of any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
surgical removal of the prostate
Highly targeted radiation
Also known as: SBRT
Lowers serum testosterone
Also known as: ADT
antiandrogen
Also known as: ARN-509
Inhibits androgen synthesis
Also known as: zytiga
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.
Time frame: 6 months after recovery of testosterone
Time to Biochemical Progression
biochemical, radiographic, or clinical
Time frame: up to 5 years
Time to Radiographic Progression
per PCWG3 criteria
Time frame: up to 5 years
Time to Initiation of Additional Antineoplastic Therapy
antineoplastic therapy includes any systemic or focal anti-prostate cancer therapy
Time frame: up to 5 years
Prostate Cancer Specific Survival
Prostate cancer specific survival
Time frame: up to 5 years
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).
Time frame: Every 3 months up to a total of 21 months
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).
Time frame: up to 5 years
| Milestone | Experimental Arm |
|---|---|
| Started | 28 |
| Completed | 24 |
| Not completed | 4 |
| Withdrew: Withdrawal by subject | 4 |
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.
| Participants | Experimental Arm |
|---|---|
| Percentage of Participants With PSA<0.05ng/mL (Radical Prostatectomy) or PSA <Nadir+2ng/mL (Prostate Radiation) | 20 |
biochemical, radiographic, or clinical
| months | Experimental Arm |
|---|---|
| Time to Biochemical Progression | NA (NA to NA) |
per PCWG3 criteria
| months | Experimental Arm |
|---|---|
| Time to Radiographic Progression | NA (NA to NA) |
antineoplastic therapy includes any systemic or focal anti-prostate cancer therapy
| months | Experimental Arm |
|---|---|
| Time to Initiation of Additional Antineoplastic Therapy | NA (NA to NA) |
Prostate cancer specific survival
| percentage of participants | Experimental Arm |
|---|---|
| Prostate Cancer Specific Survival | 100 |
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).
| Score on a Scale | Experimental Arm |
|---|---|
| Month 0 | 118 (108 to 129) |
| Month 3 | 112 (103 to 122) |
| Month 6 | 115 (106 to 124) |
| Month 9 | 119 (107 to 131) |
| Month 12 | 120 (110 to 131) |
| Month 15 | 120 (108 to 131) |
| Month 18 | 122 (112 to 133) |
| Month 21 | 113 (100 to 127) |
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).
| Participants | Experimental Arm |
|---|---|
| Grade 2 | 19 |
| Grade 3 | 2 |
| Grade 4 | 1 |
Collected over Adverse events were collected for 60 months after start date.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental Arm | 0/28 (0%) | 1/28 (3.6%) | 21/28 (75%) |
| Event | Experimental Arm |
|---|---|
| hypokalemiaBlood and lymphatic system disorders | 1/28 |
| Event | Experimental Arm |
|---|---|
| hypertensionCardiac disorders | 7/28 |
| incontinenceRenal and urinary disorders | 7/28 |
| urinary flow requiring tamsulosinRenal and urinary disorders | 4/28 |
| rashSkin and subcutaneous tissue disorders | 3/28 |
| transaminitisHepatobiliary disorders | 2/28 |
| urinary urgencyRenal and urinary disorders | 2/28 |
| hypertensionCardiac disorders | 1/28 |
| concentration impairmentNervous system disorders | 1/28 |
| cystitisRenal and urinary disorders | 1/28 |
| rectal proctitisGastrointestinal disorders | 1/28 |
| Age, Continuous(years) | Experimental Arm |
|---|---|
| Median | 69 (62 to 86) |
| Sex: Female, Male(Participants) | Experimental Arm |
|---|---|
| Female | 0 |
| Male | 28 |
| Ethnicity (NIH/OMB)(Participants) | Experimental Arm |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 23 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Experimental Arm |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 9 |
| White | 19 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Experimental Arm |
|---|---|
| United States | 28 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drugs tested here: Leuprolide · Apalutamide · Abiraterone
VA Office of Research and Development →