A Phase 2 interventional study of Apalutamide and Androgen deprivation in Prostate Cancer, sponsored by Andrew J. Armstrong, MD. Completed at 5 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-19.
Sponsored by Andrew J. Armstrong, MD · Phase 2, Interventional, and Treatment
The purpose of this study is to describe the rate of 3-year progression free survival in men with recurrent PSA-only disease after prostatectomy, who receive combined apalutamide (ARN-509) and standard ADT with salvage radiation therapy followed by docetaxel, ADT, and apalutamide, AND who have had testosterone recovery to >100 ng/dl at 36 months. The hypothesis is that AR inhibition with apalutamide added to standard salvage external beam radiation with androgen deprivation therapy, as well as the addition of 6 cycles of docetaxel, will further prolong progression free survival.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 39 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Andrew J. Armstrong, MD is the lead sponsor of 5 studies on the registry; none are open to participants now.
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.
Adequate laboratory parameters
Exclusion Criteria:
The following medications are prohibited within 2 weeks of enrollment and while on study drug:
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.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
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.
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).
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.
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.
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.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
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.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (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.
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.
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.
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.
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.
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.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
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.
Subjects with recurrent PSA-only prostate cancer within 4 years of prostatectomy, and a PSA of greater than 0.2 ng/mL and less than 4 ng/mL in the absence of metastatic disease on CT and bone scans.
Drug: Apalutamide · Drug: Androgen deprivation · Radiation: Salvage radiation therapy · Drug: Docetaxel
240mg tablet daily for 36 weeks
Also known as: ARN-509, JNJ-56021927
ADT will consist of treatment with a GnRH agonist or antagonist per physician and institutional preference. Either leuprolide acetate (Lupron Depot, 22.5 mg or 45 mg IM), triptorelin pamoate (Trelstar, 11.25 mg or 22.5 mg IM), goserelin acetate (Zoladex, 10.8mg SC) or degarelix (Firmagon 120 mg or 240 mg SC) will be administered monthly, every 3 months, or every 6 months, depending on institutional standards, for 36 weeks total.
On week 9 (+/- 28 days), subjects will begin salvage radiation therapy to the prostate bed. The total dose to the prostate bed must be 66-74 Gy in 1.8-2 Gy daily fractions over a total of 6-8 weeks
About 4 weeks (+/- 2 weeks, pending recovery of adverse events from radiation to Grade 2 or less) after completing radiation, patients will start docetaxel 75mg/m2 intravenously, every 3 weeks for 6 cycles.
Progression-free Survival (PFS) at 36 Months (3 Years)
The percentage of subjects with testosterone \>100 ng/dl at 36 months post-Cycle 1 Day 1 without one or more of the following: Serum PSA value of 0.2 ng/mL or more above the post-radiotherapy PSA nadir and confirmed (at least) 4 weeks later by a second PSA measurement higher than the first by any amount; Continued rise in the PSA level following study treatment if no nadir is experienced, defined as 2 rising values greater than the baseline PSA and separated by at least 4 weeks; Evidence of clinical progression or initiation of systemic therapy for progressive disease; Death
Time frame: up to 36 months
Number of Participants With a PSA of <0.1 ng/mL and Testosterone Recovery at 12 Months Post-Cycle 1 Day 1
Testosterone recovery defined as testosterone \>100 ng/dl
Time frame: 12 months
Percentage of Participants With a PSA of <0.1 ng/mL and Testosterone Recovery at 24 Months Post-Cycle 1 Day 1
Testosterone recovery defined as testosterone \>100 ng/dl
Time frame: 24 months
Percentage of Participants With a PSA of <0.1 ng/mL and Testosterone Recovery at 36 Months Post-Cycle 1 Day 1
Testosterone recovery defined as testosterone \>100 ng/dl
Time frame: 36 months
Biochemical Progression-free Survival (PFS) at 36 Months (3 Years)
Percentage of participants still alive without disease progression based on PSA (prostate-specific antigen) only. Must have serum PSA value of 0.2 ng/mL or more above the post-radiotherapy PSA nadir and confirmed (at least) 4 weeks later by a second PSA measurement higher than the first by any amount.
Time frame: 36 months
Median PSA Nadir Value
Median PSA nadir value
Time frame: 36 months
Time to Testosterone Recovery
Testosterone recovery defined as testosterone \>100 ng/dl
Time frame: up to 36 months
Percentage of Participants With Adverse Events as Assessed by CTCAE v4.0
To describe the safety, feasibility and tolerability profile of combination apalutamide, ADT, and radiation therapy followed by apalutamide, ADT, and docetaxel as assessed by NCI common toxicity scales
Time frame: up to 36 months
Percentage of Participants Completing All Treatments
To describe the percentage of participants completing all treatments including salvage radiation therapy and 6 cycles of docetaxel
Time frame: 36 months
| Milestone | Recurrent PSA-only Non-metastatic Prostate Cancer |
|---|---|
| Started | 39 |
| Completed | 38 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
The percentage of subjects with testosterone \>100 ng/dl at 36 months post-Cycle 1 Day 1 without one or more of the following: Serum PSA value of 0.2 ng/mL or more above the post-radiotherapy PSA nadir and confirmed (at least) 4 weeks later by a second PSA measurement higher than the first by any amount; Continued rise in the PSA level following study treatment if no nadir is experienced, defined as 2 rising values greater than the baseline PSA and separated by at least 4 weeks; Evidence of clinical progression or initiation of systemic therapy for progressive disease; Death
| percentage of participants | Recurrent PSA-only Non-metastatic Prostate Cancer |
|---|---|
| Progression-free Survival (PFS) at 36 Months (3 Years) | 69.2 (56.5 to 86.5) |
Testosterone recovery defined as testosterone \>100 ng/dl
| Participants | Recurrent PSA-only Non-metastatic Prostate Cancer |
|---|---|
| Number of Participants With a PSA of <0.1 ng/mL and Testosterone Recovery at 12 Months Post-Cycle 1 Day 1 | 38 |
Testosterone recovery defined as testosterone \>100 ng/dl
| percentage of participants | Recurrent PSA-only Non-metastatic Prostate Cancer |
|---|---|
| Percentage of Participants With a PSA of <0.1 ng/mL and Testosterone Recovery at 24 Months Post-Cycle 1 Day 1 | 67 |
Testosterone recovery defined as testosterone \>100 ng/dl
| percentage of participants | Recurrent PSA-only Non-metastatic Prostate Cancer |
|---|---|
| Percentage of Participants With a PSA of <0.1 ng/mL and Testosterone Recovery at 36 Months Post-Cycle 1 Day 1 | 69 |
Percentage of participants still alive without disease progression based on PSA (prostate-specific antigen) only. Must have serum PSA value of 0.2 ng/mL or more above the post-radiotherapy PSA nadir and confirmed (at least) 4 weeks later by a second PSA measurement higher than the first by any amount.
| percentage of participants | Recurrent PSA-only Non-metastatic Prostate Cancer |
|---|---|
| Biochemical Progression-free Survival (PFS) at 36 Months (3 Years) | 69.2 (56.5 to 86.5) |
Median PSA nadir value
| ng/mL | Recurrent PSA-only Non-metastatic Prostate Cancer |
|---|---|
| Median PSA Nadir Value | NA ± NA |
Testosterone recovery defined as testosterone \>100 ng/dl
| months | Recurrent PSA-only Non-metastatic Prostate Cancer |
|---|---|
| Time to Testosterone Recovery | 15 (13 to 17) |
To describe the safety, feasibility and tolerability profile of combination apalutamide, ADT, and radiation therapy followed by apalutamide, ADT, and docetaxel as assessed by NCI common toxicity scales
| percentage of participants | Recurrent PSA-only Non-metastatic Prostate Cancer |
|---|---|
| Percentage of Participants With Adverse Events as Assessed by CTCAE v4.0 | 100 |
To describe the percentage of participants completing all treatments including salvage radiation therapy and 6 cycles of docetaxel
| percentage of participants | Recurrent PSA-only Non-metastatic Prostate Cancer |
|---|---|
| Percentage of Participants Completing All Treatments | 97.4 |
Collected over 36 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Recurrent PSA-only Non-metastatic Prostate Cancer | 0/39 (0%) | 4/39 (10.3%) | 39/39 (100%) |
| Event | Recurrent PSA-only Non-metastatic Prostate Cancer |
|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 2/39 |
| FeverGeneral disorders | 1/39 |
| Flu like symptomsGeneral disorders | 1/39 |
| HematomaVascular disorders | 1/39 |
| Pelvic infectionInfections and infestations | 1/39 |
| Sinus tachycardiaCardiac disorders | 1/39 |
| Thromboembolic eventVascular disorders | 1/39 |
| Event | Recurrent PSA-only Non-metastatic Prostate Cancer |
|---|---|
| Hot flashesVascular disorders | 39/39 |
| FatigueGeneral disorders | 35/39 |
| White blood cell decreasedInvestigations | 33/39 |
| Neutrophil count decreasedInvestigations | 32/39 |
| AlopeciaSkin and subcutaneous tissue disorders | 30/39 |
| AnemiaBlood and lymphatic system disorders | 25/39 |
| DysgeusiaNervous system disorders | 23/39 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 21/39 |
| InsomniaPsychiatric disorders | 18/39 |
| Urinary frequencyRenal and urinary disorders | 18/39 |
| Age, Continuous(years) | Recurrent PSA-only Non-metastatic Prostate Cancer |
|---|---|
| Mean | 63.2 ± 6.6 |
| Sex: Female, Male(Participants) | Recurrent PSA-only Non-metastatic Prostate Cancer |
|---|---|
| Female | 0 |
| Male | 39 |
| Ethnicity (NIH/OMB)(Participants) | Recurrent PSA-only Non-metastatic Prostate Cancer |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 37 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Recurrent PSA-only Non-metastatic Prostate Cancer |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 34 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(Participants) | Recurrent PSA-only Non-metastatic Prostate Cancer |
|---|---|
| United States | 39 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drugs tested here: Apalutamide · Docetaxel
Andrew J. Armstrong, MD