Clinical Trials List
Protocol NumberMDV3100-14
NCT Number(ClinicalTrials.gov Identfier)NCT02003924
Completed
2013-09-01 - 2024-03-31
Phase III
Terminated11
ICD-10C61
Malignant neoplasm of prostate
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9185
Malignant neoplasm of prostate
PROSPER: A Multinational, Phase 3, Randomized, Double‑Blind, Placebo‑Controlled, Efficacy and Safety Study of Enzalutamide in Patients With Nonmetastatic Castration‑Resistant Prostate Cancer
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Trial Applicant
-
Sponsor
Medivation, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Principal Investigator
Co-Principal Investigator
- Chuan-Shu Chen Division of Urology
- Jian-Ri Li Division of Urology
- Cheng-Kuang Yang Division of Urology
- 熊小澐 Division of Radiology
- Shian-Shiang Wang Division of Urology
- 歐宴泉 Division of Urology
- 林萬鈺 Division of Urology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Jian-Ri Li Division of Urology
- Shian-Shiang Wang Division of Urology
- 余家政 Division of Urology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Terminated
Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Hung-Lung Ke Division of Urology
- 黃俊農 Division of Urology
- Yung-Chin Lee Division of Urology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 洪志宏 Division of Radiation Therapy
- Rita cheng Division of Hematology & Oncology
- See-Tong Pang Division of Hematology & Oncology
- 范綱行 Division of Radiation Therapy
- 張英勛 Division of Hematology & Oncology
- 吳俊德 Division of Urology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Pei-Hung Chang Division of Hematology & Oncology
- 林承家 Division of Urology
- 黃賢祥 Division of Urology
- 陳文祥 Division of Urology
- 陳彥超 Division of Radiation Therapy
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Yen-Hwa Chang Division of Urology
- 沈書慧 Division of Urology
- 朱力行 Division of Urology
- Yi-Hsiu Huang Division of Urology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Wen-Chi Chen Division of Urology
- Chi-Ping Huang Division of Urology
- Chi-Rei Yang Division of Urology
- Chao-Hsiang Chang Division of Urology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- - - Division of Urology
- Chia-Chi Lin Division of Hematology & Oncology
- - - Division of Urology
- 戴槐青 Division of Urology
- SHUO-MENG WANG Division of Urology
- Yu-Chieh Tsai Division of Hematology & Oncology
- CHUNG-HSIN CHEN Division of Urology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Nonmetastatic Castration Resistant Prostate Cancer
Objectives
Primary:
To determine the efficacy of enzalutamide compared with placebo as assessed by metastasis-free survival
(MFS).
Secondary:
To evaluate the benefit of enzalutamide compared with placebo as measured by the following:
Overall survival;
Time to pain progression;
Time to opiate use for prostate cancer pain;
Time to pain progression or opiate use for prostate cancer pain;
Time to first use of cytotoxic chemotherapy;
Time to first use of new antineoplastic therapy;
Time to prostate-specific antigen (PSA) progression;
PSA response rates;
Time to functional status deterioration as assessed by the Functional Assessment of Cancer
Therapy-Prostate (FACT-P) global score;
Quality of life as assessed by the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) health
questionnaire and Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) module.
To evaluate safety.
Test Drug
Enzalutamide
Active Ingredient
Enzalutamide
Dosage Form
capsule
Dosage
40mg
Endpoints
Primary Efficacy Endpoint:
The primary efficacy endpoint of MFS is defined as the time from randomization to radiographic progression or death on study (death within 112 days of treatment discontinuation without evidence of radiographic progression), whichever occurs first. Assessment of bone and soft tissue disease will be as described in the Methods section. Assessment of images for determination of progression will be made by an independent, central, blinded radiology reviewer.
The primary endpoint analysis will be performed when at least 574 MFS events and at least 480 deaths are observed. A stratified log-rank test will be used to compare the treatment groups using a 2-sided test at the 0.05 level of significance.
The primary efficacy endpoint of MFS is defined as the time from randomization to radiographic progression or death on study (death within 112 days of treatment discontinuation without evidence of radiographic progression), whichever occurs first. Assessment of bone and soft tissue disease will be as described in the Methods section. Assessment of images for determination of progression will be made by an independent, central, blinded radiology reviewer.
The primary endpoint analysis will be performed when at least 574 MFS events and at least 480 deaths are observed. A stratified log-rank test will be used to compare the treatment groups using a 2-sided test at the 0.05 level of significance.
Inclution Criteria
Inclusion Criteria
Each patient eligible to participate in this study must meet all of the following criteria:
1. Age 18 years or older and willing and able to provide informed consent;
2. Histologically or cytologically confirmed adenocarcinoma of the prostate without
neuroendocrine differentiation, signet cell, or small cell features;
3. Ongoing androgen deprivation therapy with a GnRH agonist/antagonist or prior bilateral
orchiectomy (medical or surgical castration);
4. Testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening;
5. For patients receiving bisphosphonates or denosumab, dose must be stable for at least
4 weeks before randomization;
6. Progressive disease on androgen deprivation therapy at enrollment defined as a minimum
of 3 rising PSA values (PSA1 < PSA2 < PSA3) assessed by a local laboratory (local
PSA) with an interval of ≥ 1 week between each determination;
7. The most recent local PSA and the screening PSA assessed by the central laboratory
(central PSA) should be ≥ 2 µg/L (2 ng/mL). In the event of prior androgen receptor
inhibitor use, the most recent local PSA and the central PSA assessed at screening must
be obtained at least 4 weeks after the last dose of the androgen receptor inhibitor;
8. PSA doubling time ≤ 10 months calculated by the sponsor using the method of
Pound et al, 1999;11
9. No prior or present evidence of metastatic disease as assessed by CT/MRI for soft tissue
disease and whole-body radionuclide bone scan for bone disease. If the screening bone
scan shows a lesion suggestive of metastatic disease, the patient will be eligible only if a
second imaging modality (plain film, CT, or MRI) does not show bone metastasis. If the
imaging results are equivocal or consistent with metastasis, the patient is not eligible for enrollment. Patients with soft tissue pelvic disease may be eligible if lesions do not
qualify as target lesions (eg, lymph nodes below aortic bifurcation are permissible if the
short axis of the largest lymph node is < 15 mm);
10. Asymptomatic prostate cancer;
11. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
12. Estimated life expectancy ≥ 12 months;
13. Able to swallow the study drug and comply with study requirements;
14. Male patient and his female partner who is of childbearing potential must use
2 acceptable methods of birth control (1 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. Two acceptable methods of birth
control thus include the following:
Condom (barrier method of contraception);
AND
One of the following is required:
- Established use of oral, or injected or implanted hormonal method of
contraception by the female partner;
- Placement of an intrauterine device (IUD) or intrauterine system (IUS) by the
female partner;
- Additional barrier method: Occlusive cap (diaphragm or cervical/vault caps) with
spermicidal foam/gel/film/cream/suppository in the female partner;
- Tubal ligation in the female partner;
- Vasectomy or other procedure resulting in infertility (eg, bilateral orchiectomy),
for more than 6 months.
15. Male patient must use a condom if having sex with a pregnant woman.
Each patient eligible to participate in this study must meet all of the following criteria:
1. Age 18 years or older and willing and able to provide informed consent;
2. Histologically or cytologically confirmed adenocarcinoma of the prostate without
neuroendocrine differentiation, signet cell, or small cell features;
3. Ongoing androgen deprivation therapy with a GnRH agonist/antagonist or prior bilateral
orchiectomy (medical or surgical castration);
4. Testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening;
5. For patients receiving bisphosphonates or denosumab, dose must be stable for at least
4 weeks before randomization;
6. Progressive disease on androgen deprivation therapy at enrollment defined as a minimum
of 3 rising PSA values (PSA1 < PSA2 < PSA3) assessed by a local laboratory (local
PSA) with an interval of ≥ 1 week between each determination;
7. The most recent local PSA and the screening PSA assessed by the central laboratory
(central PSA) should be ≥ 2 µg/L (2 ng/mL). In the event of prior androgen receptor
inhibitor use, the most recent local PSA and the central PSA assessed at screening must
be obtained at least 4 weeks after the last dose of the androgen receptor inhibitor;
8. PSA doubling time ≤ 10 months calculated by the sponsor using the method of
Pound et al, 1999;11
9. No prior or present evidence of metastatic disease as assessed by CT/MRI for soft tissue
disease and whole-body radionuclide bone scan for bone disease. If the screening bone
scan shows a lesion suggestive of metastatic disease, the patient will be eligible only if a
second imaging modality (plain film, CT, or MRI) does not show bone metastasis. If the
imaging results are equivocal or consistent with metastasis, the patient is not eligible for enrollment. Patients with soft tissue pelvic disease may be eligible if lesions do not
qualify as target lesions (eg, lymph nodes below aortic bifurcation are permissible if the
short axis of the largest lymph node is < 15 mm);
10. Asymptomatic prostate cancer;
11. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
12. Estimated life expectancy ≥ 12 months;
13. Able to swallow the study drug and comply with study requirements;
14. Male patient and his female partner who is of childbearing potential must use
2 acceptable methods of birth control (1 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. Two acceptable methods of birth
control thus include the following:
Condom (barrier method of contraception);
AND
One of the following is required:
- Established use of oral, or injected or implanted hormonal method of
contraception by the female partner;
- Placement of an intrauterine device (IUD) or intrauterine system (IUS) by the
female partner;
- Additional barrier method: Occlusive cap (diaphragm or cervical/vault caps) with
spermicidal foam/gel/film/cream/suppository in the female partner;
- Tubal ligation in the female partner;
- Vasectomy or other procedure resulting in infertility (eg, bilateral orchiectomy),
for more than 6 months.
15. Male patient must use a condom if having sex with a pregnant woman.
Exclusion Criteria
Exclusion Criteria
Each patient eligible to participate in this study must NOT meet any of the following
exclusion criteria:
1. Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or
enzalutamide for the treatment of prostate cancer or participation in a clinical trial of an
investigational agent that inhibits the androgen receptor or androgen synthesis (unless
treatment was placebo);
2. Treatment with hormonal therapy (eg, androgen receptor inhibitors, estrogens, 5-alpha
reductase inhibitors) or biologic therapy for prostate cancer (other than approved
bone-targeting agents and GnRH agonist/antagonist therapy) within 4 weeks of
randomization;
3. Use of an investigational agent within 4 weeks of randomization;
4. Known or suspected brain metastasis or active leptomeningeal disease;
5. History of another invasive cancer within 3 years of randomization, with the exception of
fully treated cancers with a remote probability of recurrence in the opinion of both the
medical monitor and investigator; 6. Absolute neutrophil count < 1000/μL, platelet count < 100,000/μL, or hemoglobin
< 10 g/dL (6.2 mmol/L) at screening. NOTE: may not have received growth factors or
blood transfusions within 7 days before obtaining the hematology values at screening;
7. Total bilirubin ≥ 1.5 times the upper limit of normal (ULN) (except patients with
a diagnosis of Gilbert’s disease); alanine aminotransferase (ALT) or aspartate
aminotransferase (AST) ≥ 2.5 times ULN at screening;
8. Creatinine > 2 mg/dL (177 µmol/L) at screening;
9. Albumin < 3.0 g/dL (30 g/L) at screening;
10. History of seizure or any condition that may predispose to seizure (eg, prior cortical
stroke or significant brain trauma). History of loss of consciousness or transient ischemic
attack within 12 months of randomization;
11. Clinically significant cardiovascular disease including the following:
Myocardial infarction within 6 months before screening;
Uncontrolled angina within 3 months before screening;
Congestive heart failure New York Heart Association class 3 or 4, or a history of
congestive heart failure New York Heart Association class 3 or 4, unless a screening
echocardiogram or multigated acquisition scan performed within 3 months before
randomization demonstrates a left ventricular ejection fraction ≥ 50%;
History of clinically significant ventricular arrhythmias (eg, sustained ventricular
tachycardia, ventricular fibrillation, torsades de pointes);
History of Mobitz II second-degree or third-degree heart block without a permanent
pacemaker in place;
Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury
(mm Hg) at screening;
Bradycardia as indicated by a heart rate of < 45 beats per minute on the screening
electrocardiogram (ECG) and on physical examination;
Uncontrolled hypertension as indicated by systolic blood pressure > 170 mm Hg or
diastolic blood pressure > 105 mm Hg at screening.
12. Gastrointestinal disorder affecting absorption (eg, gastrectomy, active peptic ulcer
disease within 3 months before randomization);
13. Major surgery within 4 weeks of randomization;
14. Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule
components, including Labrasol, butylated hydroxyanisole, and butylated
hydroxytoluene;
15. Any concurrent disease, infection, or comorbid condition that interferes with the ability
of the patient to participate in the trial, which places the patient at undue risk, or
complicates the interpretation of data, in the opinion of the investigator or medical
monitor.
Each patient eligible to participate in this study must NOT meet any of the following
exclusion criteria:
1. Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or
enzalutamide for the treatment of prostate cancer or participation in a clinical trial of an
investigational agent that inhibits the androgen receptor or androgen synthesis (unless
treatment was placebo);
2. Treatment with hormonal therapy (eg, androgen receptor inhibitors, estrogens, 5-alpha
reductase inhibitors) or biologic therapy for prostate cancer (other than approved
bone-targeting agents and GnRH agonist/antagonist therapy) within 4 weeks of
randomization;
3. Use of an investigational agent within 4 weeks of randomization;
4. Known or suspected brain metastasis or active leptomeningeal disease;
5. History of another invasive cancer within 3 years of randomization, with the exception of
fully treated cancers with a remote probability of recurrence in the opinion of both the
medical monitor and investigator; 6. Absolute neutrophil count < 1000/μL, platelet count < 100,000/μL, or hemoglobin
< 10 g/dL (6.2 mmol/L) at screening. NOTE: may not have received growth factors or
blood transfusions within 7 days before obtaining the hematology values at screening;
7. Total bilirubin ≥ 1.5 times the upper limit of normal (ULN) (except patients with
a diagnosis of Gilbert’s disease); alanine aminotransferase (ALT) or aspartate
aminotransferase (AST) ≥ 2.5 times ULN at screening;
8. Creatinine > 2 mg/dL (177 µmol/L) at screening;
9. Albumin < 3.0 g/dL (30 g/L) at screening;
10. History of seizure or any condition that may predispose to seizure (eg, prior cortical
stroke or significant brain trauma). History of loss of consciousness or transient ischemic
attack within 12 months of randomization;
11. Clinically significant cardiovascular disease including the following:
Myocardial infarction within 6 months before screening;
Uncontrolled angina within 3 months before screening;
Congestive heart failure New York Heart Association class 3 or 4, or a history of
congestive heart failure New York Heart Association class 3 or 4, unless a screening
echocardiogram or multigated acquisition scan performed within 3 months before
randomization demonstrates a left ventricular ejection fraction ≥ 50%;
History of clinically significant ventricular arrhythmias (eg, sustained ventricular
tachycardia, ventricular fibrillation, torsades de pointes);
History of Mobitz II second-degree or third-degree heart block without a permanent
pacemaker in place;
Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury
(mm Hg) at screening;
Bradycardia as indicated by a heart rate of < 45 beats per minute on the screening
electrocardiogram (ECG) and on physical examination;
Uncontrolled hypertension as indicated by systolic blood pressure > 170 mm Hg or
diastolic blood pressure > 105 mm Hg at screening.
12. Gastrointestinal disorder affecting absorption (eg, gastrectomy, active peptic ulcer
disease within 3 months before randomization);
13. Major surgery within 4 weeks of randomization;
14. Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule
components, including Labrasol, butylated hydroxyanisole, and butylated
hydroxytoluene;
15. Any concurrent disease, infection, or comorbid condition that interferes with the ability
of the patient to participate in the trial, which places the patient at undue risk, or
complicates the interpretation of data, in the opinion of the investigator or medical
monitor.
The Estimated Number of Participants
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Taiwan
132 participants
-
Global
1560 participants
