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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recurrent PSA-only non-metastatic prostate cancer | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apalutamide | Drug | 240mg tablet daily for 36 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Percentage of Participants With a PSA of <0.1 ng/mL and Testosterone Recovery at 24 Months Post-Cycle 1 Day 1 |
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Inclusion Criteria:
Histologically-confirmed diagnosis of prostate adenocarcinoma. Variants of prostate cancer, including neuroendocrine features and small cell carcinoma of the prostate, are not permitted.
Gleason sum of 7 (with pT3 disease or positive margins or positive nodes [4 or fewer]), 8, 9, or 10 based on the radical prostatectomy specimen
PSA relapse within 4 years of prostatectomy defined by persistently detectable or rising PSA after surgery.
Evidence of disease recurrence or progression as evidenced by a PSA > 0.20. This requires 2 consecutive rises in PSA, at least 1 week apart, over the post-prostatectomy nadir OR one PSA value above 0.20 ng/mL IF the patient failed to achieve a post-prostatectomy nadir of < 0.2 ng/mL.
Age ≥ 18 years
Karnofsky performance status ≥ 80
Adequate laboratory parameters
A minimum of 4 weeks from any major surgery prior to Cycle 1 Day 1.
Ability to swallow, retain, and absorb oral medication.
Ability to understand and the willingness to sign a written informed consent document.
Must use a condom if having sex with a pregnant woman.
Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration.
Exclusion Criteria:
Radiographic evidence of metastatic disease. Patients with node-positive disease (≤4 positive nodes) at the time of radical prostatectomy are eligible. Patients with pelvic nodes less than 1.5 cm by short axis at the time of screening are eligible. Patients with any enlarged lymph nodes in the retroperitoneum or above the aortic bifurcation or with pelvic nodes ≥ 1.5 cm must be excluded.
PSA ≥ 4.0 ng/mL.
Testosterone level ≤ 100 ng/dL.
More than 1 month of prior hormone exposure or hormone exposure within 30 days of enrollment (up to 1 month of prior LHRH agonist and/or anti-androgen therapy as neoadjuvant therapy prior to prostatectomy is allowed). Prior enzalutamide, apalutamide, ketoconazole, abiraterone, or TAK700 for prostate cancer are prohibited. Prior antiandrogen therapy (including but not limited to bicalutamide, flutamide, nilutamide, enzalutamide, and apalutamide) and prior estrogen therapy (including estrogen patch) are not allowed. All investigational agents are prohibited within 30 days of enrollment.
The following medications are prohibited within 2 weeks of enrollment and while on study drug:
Prior immunotherapy including sipuleucel-T.
Prior systemic chemotherapy (docetaxel, cabazitaxel, estramustine, other cytotoxic agents)
History of solid organ or stem cell transplantation.
History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke, prior head or traumatic brain injury with loss of consciousness, prior or current space-occupying lesion in the brain). Also, history of loss of consciousness or transient ischemic attack within 12 months of Day 1 visit.
Known or suspected brain metastasis or active leptomeningeal disease.
Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol.
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 enrollment
Sustained uncontrolled hypertension (>150/90 average over 1 week) despite optimal medical management
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of apalutamide or increase the risk of radiation (e.g., uncontrolled nausea, vomiting, diarrhea, malabsorption syndromes, prior small bowel resection, or inflammatory bowel disease).
Patients who have received prior prostate or pelvic radiotherapy, including external beam or brachytherapy.
Patients who have not recovered from side effects of prior systemic therapy prior to Cycle 1 Day 1.
Use of medications known to lower the seizure threshold within 4 weeks prior to study entry.
Patients unable or unwilling to abide by the study protocol or cooperate fully with the investigator.
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| Name | Affiliation | Role |
|---|---|---|
| Tian Zhang, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GU Research Network / Urology Cancer Center | Omaha | Nebraska | 68130 | United States | ||
| Weill Cornell Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Recurrent PSA-only Non-metastatic Prostate Cancer | 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. Apalutamide: 240mg tablet daily for 36 weeks Androgen deprivation: 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. Salvage radiation therapy: 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 Docetaxel: 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 15, 2021 |
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| Androgen deprivation | Drug | 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. |
|
| Salvage radiation therapy | Radiation | 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 |
|
| Docetaxel | Drug | 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. |
|
Testosterone recovery defined as testosterone >100 ng/dl |
| 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 | 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. | 36 months |
| Median PSA Nadir Value | Median PSA nadir value | 36 months |
| Time to Testosterone Recovery | Testosterone recovery defined as testosterone >100 ng/dl | 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 | 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 | 36 months |
| New York |
| New York |
| 10065 |
| United States |
| Duke Cancer Center Cary | Cary | North Carolina | 27518 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Wake Forest Univesity | Winston-Salem | North Carolina | 27157 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Recurrent PSA-only Non-metastatic Prostate Cancer | 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. Apalutamide: 240mg tablet daily for 36 weeks Androgen deprivation: 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. Salvage radiation therapy: 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 Docetaxel: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | 95% Confidence Interval | percentage of participants | up to 36 months |
|
|
| ||||||||||||||||||||||||||
| Secondary | 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 | Posted | Count of Participants | Participants | 12 months |
|
| ||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Number | percentage of participants | 24 months |
|
| ||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Number | percentage of participants | 36 months |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 36 months |
| ||||||||||||||||||||||||||||
| Secondary | Median PSA Nadir Value | Median PSA nadir value | Posted | Median | Standard Deviation | ng/mL | 36 months |
|
| |||||||||||||||||||||||||||
| Secondary | Time to Testosterone Recovery | Testosterone recovery defined as testosterone >100 ng/dl | Posted | Median | 95% Confidence Interval | months | up to 36 months |
|
| |||||||||||||||||||||||||||
| Secondary | 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 | Posted | Number | percentage of participants | up to 36 months |
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Completing All Treatments | To describe the percentage of participants completing all treatments including salvage radiation therapy and 6 cycles of docetaxel | Posted | Number | percentage of participants | 36 months |
|
|
36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Recurrent PSA-only Non-metastatic Prostate Cancer | 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. Apalutamide: 240mg tablet daily for 36 weeks Androgen deprivation: 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. Salvage radiation therapy: 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 Docetaxel: 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. | 0 | 39 | 4 | 39 | 39 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Flu like symptoms | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pelvic infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injury, poisoning and procedural complications - Other, Specify | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Paroxysmal atrial tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ear and labyrinth disorders - Other, Specify | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry eye | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Eye disorders - Other, Specify | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Photophobia | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Watering eyes | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastrointestinal disorders - Other, Specify | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Oral dysesthesia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rectal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema face | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Flu like symptoms | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, Specify | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infusion related reaction | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Localized edema | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Malaise | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and infestations - Other, Specify | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucosal infection | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Otitis externa | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Papulopustular rash | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pelvic infection | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Penile infection | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin infection | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Upper respiratory infection | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary tract infection | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Weight gain | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Alkalosis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypercalcemia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypomagnesemia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyponatremia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Buttock pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle weakness left-sided | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder - Other Specify | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Concentration impairment | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysesthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nervous system disorders - Other, Specify | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Radiculitis | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sinus pain | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Psychiatric disorders - Other, Specify | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Renal and urinary disorders - Other, Specify | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary urgency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gynecomastia | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Perineal pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Testicular disorder | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Testicular pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bullous dermatitis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nail discoloration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nail loss | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nail ridging | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, Specify | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Surgical and medical procedures - Other, Specify | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Superficial thrombophlebitis | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Armstrong, MD | Duke University | 919-668-8797 | andrew.armstrong@duke.edu |
| Nov 16, 2023 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C572045 | apalutamide |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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