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| Name | Class |
|---|---|
| Medivation LLC, a wholly owned subsidiary of Pfizer Inc. | INDUSTRY |
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The primary purpose of this study was to compare the time to prostate cancer progression (pathological or therapeutic progression) between patients treated with enzalutamide versus patients undergoing active surveillance.
This was a multicenter, randomized, open label exploratory study, conducted in the US and Canada, evaluating the efficacy and safety of enzalutamide for extension of time to prostate cancer progression (pathological or therapeutic) in patients with clinically localized, histologically proven prostate cancer that is categorized as low risk or intermediate risk and who were under AS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzalutamide | Active Comparator | Participants received 160-milligrams (mg) enzalutamide administered as four 40-mg capsules, orally once daily for 1 year of treatment period. Following the 1-year treatment period, all participants were followed for 1 additional year. Post the 1-year follow-up period, participants then started the continued follow-up period, in which, participants were followed up every 3 months for these 2 years, after which follow-up was either every 6 months up to 36 months or until the end of study (total duration of follow up in the study was approximately up to 35.9 months). |
|
| Active Surveillance (AS) | Other | Participants did not receive any study treatment in this arm but were on continued active surveillance (AS) for 1 year of treatment period. Following the 1-year treatment period, all participants were followed for 1 additional year. Post the 1-year follow up, participants then started the continued follow-up period, in which, participants were followed up every 3 months for these 2 years, after which follow-up was either every 6 months up to 36 months or until the end of study (total duration of follow up in the study was approximately up to 35.9 months). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzalutamide | Drug | Oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Prostate Cancer Progression | Time to cancer prostate progression (pathological or therapeutic): time (in months) from date of randomization until the date of cancer progression (pathological or therapeutic). Pathological progression: increase in primary or secondary Gleason pattern by greater than or equal (>=) 1 or higher proportion of cancer positive cores (>=15 percent [%] increase). Therapeutic progression: earliest occurrence of primary therapy for prostate cancer (prostatectomy/radiation/focal therapy/systemic therapy). Medians and 95% CIs were calculated with the Kaplan-Meier (KM) method. Participants with no cancer progression at the time of study completion, discontinuation or death were censored at the last assessment date. Participants switching therapy during the study were censored at the time of the initial therapy switch, and participants discontinuing therapy were censored at the time of study discontinuation. | From the date of randomization until the date of the cancer progression (pathological or therapeutic) (up to study completion date, 28 Aug 2020; approximately 50 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | An AE: any untoward medical occurrence in a participant administered study drug or who underwent study procedures and did not necessarily had a causal relationship with treatment. An abnormality identified during a medical test: an AE only if the abnormality induced clinical signs or symptoms, required active intervention, required interruption, or discontinuation of study medication, or was clinically significant in the opinion of investigator. An AE: serious if it resulted in any of the following outcomes: Death, was life-threatening, Persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, Congenital anomaly, or birth defect, Inpatient hospitalization or prolongation of hospitalization, Other medically important event. Drug-related AEs: assessed by investigator as AEs whose relationship to study drugs could not be ruled out. |
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Inclusion Criteria:
Histologically proven adenocarcinoma of the prostate diagnosed (with ≥10 core biopsy) within 6 months of screening. The biopsy that was used for this diagnosis must be submitted for central pathology review.
Prostate cancer categorized (as determined by central pathology review) as low risk is defined as T1c-T2a, PSA<10, N0, M0 (or presumed N0, M0 if CT/bone scan not done due to low risk of metastases), GS ≤ 6, ECOG status ≤2 and estimated life expectancy >5 years OR intermediate risk is defined as T2b-T2c, PSA<20, N0, M0 (or presumed N0, M0 if CT/bone scan not done), GS ≤7 (3+4 pattern only), ECOG status ≤ 2 and estimated life expectancy > 5 years. Prostate cancer categorized (as determined by central pathology review) to the very low risk category (T1c, GS ≤6, PSA <10 ng/mL, fewer than 3 prostate biopsy cores positive,
≤50% cancer in any core, PSA density <0.15 ng/mL/g) is not included.
Ability to swallow study drugs and to comply with study requirements throughout the study
Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures
Throughout study, male subject and a female partner who is of childbearing potential must use two acceptable methods of birth control (one of which must include a condom barrier method of contraception) starting at screening and continuing throughout the study period and for three months after the final study drug administration. Two acceptable methods of birth control thus include the following:
i. Established use of oral, injected or implanted hormonal methods of contraception by the female partner; ii. Placement of an intrauterine device or intrauterine system by the female partner; iii. Additional barrier method: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam / gel / film / cream / suppository by the female partner; iv. Tubal ligation in the female partner.
Must not donate sperm starting at screening throughout the study period and for 90 days after the final study drug administration.
Exclusion Criteria:
Prior radiotherapy, surgery, chemotherapy, or hormonal therapy for prostate cancer
Very low risk category (T1c, GS ≤6, PSA <10 ng/mL, fewer than 3 prostate biopsy cores positive, ≤50% cancer in any core, PSA density <0.15 ng/mL/g)
Prior transurethral resection of the prostate or prior transurethral microwave thermotherapy of the prostate
Use of oral glucocorticoids within 1 month of screening
Use of 5 alpha reductase inhibitor within 1 month of screening or total use, within the last two years prior to screening, of >3 months
Presence of metastatic disease
History of seizure or any condition that may predispose to seizures at any time in the past. History of loss of consciousness or transient ischemic attack within 12 months of screening
Absolute neutrophil count < 1,500/μL, platelet count < 100,000/μL, or hemoglobin < 6.2 mmol/L (10 g/dL) at screening
Total bilirubin >1.5 times the upper limit of normal (ULN) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 X ULN at screening
Creatinine > 177 μmol/L (> 2 mg/dL) at screening
Albumin < 30 g/L (3.0 g/dL) at screening
Major surgery within 4 weeks prior to Randomization Visit
Clinically significant cardiovascular disease including:
Known hypersensitivity to enzalutamide or any of its components.
Subject has received investigational therapy within 28 days or 5 half lives, whichever is longer, prior to screening
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Global Development, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site US10034 | Birmingham | Alabama | 35223 | United States | ||
| Site US10024 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40742002 | Derived | Handa N, Shore ND, Cooperberg MR, Davicioni E, Zhao X, Elsouda D, Liu Y, Proudfoot JA, Kuperman G, Russell D, Iwata KK, Schaeffer EM, Ross A. Transcriptome profiling of prostatic tumours from ENACT trial patients with or without enzalutamide. BJU Int. 2025 Nov;136(5):920-929. doi: 10.1111/bju.16861. Epub 2025 Jul 31. | |
| 38635932 | Derived |
| Label | URL |
|---|---|
| Link to results and other applicable study documents on the Astellas Clinical Trials website | View source |
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Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Randomization was stratified according to prostate cancer risk (low and intermediate) and type of biopsy performed (mpMRI-targeted and non-mpMRI-targeted). Out of 310 participants who were screened, 83 participants were considered screen failures.
Adult participants with clinically localized, histologically proven prostate cancer diagnosed within 6 months of screening and had been on active surveillance were enrolled in this study. Participants were categorized as low risk or intermediate risk and had a minimum of 10 cores from transrectal ultrasound-guided prostate biopsy (multiparametric magnetic resonance imaging [mpMRI]-targeted versus non-mpMRI-targeted) done within 6 months prior to screening visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enzalutamide | The study has 3 parts: treatment period, 1 year follow-up period and continued follow-up period. Participants received 160-miligram (mg) enzalutamide administered as four 40-mg capsules, orally once daily for 1 year of treatment period. Following the 1-year treatment period, all participants were followed for 1 additional year. Post the 1-year follow-up period, participants then started the continued follow-up period, in which, participants were followed up every 3 months for these 2 years, after which follow-up was either every 6 months up to 36 months or until the end of study (total duration of follow up in the study was approximately up to 35.9 months). |
| 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 | Yes | No | No | Study Protocol | Dec 18, 2015 | Oct 14, 2021 |
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| Active Surveillance | Other |
|
| From date of first dose of enzalutamide or randomization until end of study (up to study completion date, 28 Aug 2020; approximately 50 months) |
| Percentage of Participants Reported Negative Biopsies for Cancer | Percentage of Participants who reported negative biopsies for cancer were reported. | At the end of months 12 and 24 |
| Change From Baseline in Percent of Cancer Positive Cores at Month 12 and 24 | Percent positive cores were calculated using the number of systemically sampled prostate regions and any targeted regions with at least 1 positive core divided by the total number of systematically sampled regions and targeted regions. This implied that despite the number of samples within a given systematic or targeted region, any positive core indicated that region as positive. | Baseline, months 12 and 24 |
| Time to Prostate-specific Antigen (PSA) Progression | Time to PSA progression was defined as time in months from the date of randomization or first dose enzalutamide untill date of PSA progression (secondary rise in serum PSA >=25% above baseline or >=25% above nadir or absolute increase >= 2 nanogram per mililiter [ng/mL]). Participants with no PSA progression at the time of trial completion, discontinuation or death were censored at the last assessment date. Additionally, participants switching therapy during the study were censored at the time of the initial therapy switch, and participants discontinuing therapy were censored at the time of study discontinuation. Medians and 95% CIs were calculated with the KM method. | From date of randomization or first dose of enzalutamide until date of PSA progression (pathological or therapeutic) (up to study completion date=28 Aug 2020, median duration: 14.82 months for "Enzalutamide", 8.80 months for "Active Surveillance") |
| Percentage of Participants With Secondary Rise in Serum PSA | Percentage of participants with secondary rise in serum PSA > 25% baseline or > 25% above nadir or absolute increase >2 ng/mL were reported in this measure. | At the end of months 12, 24 and at the end of study (up to study completion date, 28 Aug 2020, approximately 50 months) |
| Change From Baseline in Brief Fatigue Inventory (BFI) Questionnaire Composite Scores to Months 3, 6, 12, 18 and 24 | The BFI is a screening tool designed to assess the severity and impact of fatigue on daily functioning of participants with cancer during the 24 hours. There are 9 items on the scale. The first three questions ask participants to rate their fatigues on a scale from 0 (no fatigue) - 10 (as bad as you can imagine), with higher scores indicating worse outcome. The remaining six questions ask participants to rate how much fatigue has interfered with their daily activities on a scale from 0 (Does not interfere) to 10 (Completely interferes). A composite fatigue score was obtained by averaging all the items on the BFI, ranged between 0 to 10, with a higher BFI fatigue score indicating worse outcome. The composite BFI score was calculated only if at least 5 of the 9 items were answered. | Baseline, months 3, 6, 12, 18 and 24 |
| Change From Baseline in 12-Item Short Form Survey (SF-12) Questionnaire Composite Score to Months 6, 12, 18, 24 - Mental Component Summary | SF-12 is a questionnaire that measures overall health related quality of life using 12 questions. The questions are then scored and weighted into 2 subscales, physical health and mental health. Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life). Scores are transformed and ranges between 0 to 100; higher score indicates improvement. | Baseline, months 6, 12, 18 and 24 |
| Change From Baseline in SF-12 Questionnaire Composite Score to Months 6, 12, 18, 24 - Physical Component Summary | SF-12 is a questionnaire that measures overall health related quality of life using 12 questions. The questions are then scored and weighted into 2 subscales, physical health and mental health. Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life). Scores are transformed and ranges between 0 to 100; higher score indicates improvement. | Baseline, months 6, 12, 18 and 24 |
| Change From Baseline in The Expanded Prostate Cancer Index Composite (EPIC) Hormonal Assessment Scores at Months 6, 12, 18 and 24 | The EPIC Hormonal Assessment was a questionnaire used to measure quality of life (QoL) issues in participants with prostate cancer. There were a total of 6 questions related to hormonal function such as hot flashes, breast tenderness, depression, lack of energy, weight fluctuation. The answers ranged from "more than once a day" to "rarely or never" (ranged from 1 to 5, corresponding standardized scores were 100, 75, 50, 25, 0), "no problem" to "big problem" (ranged from 0 to 4, corresponding standardized scores were 100, 75, 50, 25, 0). Score from each answer was converted into standardized score at each visit. Total score was calculated by taking average of standardized scores. Total score was measured on a scale ranged from 0 (worst) to 100 (best) scale with higher scores representing better hormonal function. | Baseline, months 6, 12, 18 and 24 |
| Change From Baseline in EPIC Sexual Assessment Scores at Months 6, 12, 18 and 24 | EPIC Sexual Assessment: a questionnaire to measure QoL issues in participants with prostate cancer, included a total of 9 questions on sexual function as level of sexual desire, ability to have an erection, ability to reach orgasm, quality and frequency of erections, frequency of sexual intercourse. Answers ranged from "very poor" to "very good,"(ranged from 1 - 5, corresponding standardized scores:0, 25, 50, 75, 100), "none" to "enough"(ranged from 1 - 4, corresponding standardized scores:0, 33, 67, 100), "no problem" to "big problem"(ranged from 0 - 4, corresponding standardized scores:100, 75, 50, 25, 0), and "never" to "daily"(ranged from 1 - 5, corresponding standardized scores:100, 75, 50, 25, 0). Scores from each answer was converted into standardized score at each visit. Total score = calculated by taking average of standardized scores. Total score was measured on a scale ranged from 0 (worst) to 100 (best), higher scores = better sexual function and satisfaction. | Baseline, months 6, 12, 18 and 24 |
| Change From Baseline in EPIC Urinary Assessment Scores at Month 6, 12, 18 and 24 | EPIC urinary assessment: a questionnaire to measure QoL issues in participants with prostate cancer, included a total of 7 questions on urinary function as leaking urine, blood in urine, pain/burning on urination, urinary control and frequency. Answers ranged from "more than once a day" to "rarely or never"(scores from 1 - 5,corresponding standardized scores[CSS]:0, 25, 50, 75, 100), "no urinary control" to "full urinary control"(scores from 1 - 4,CSS:0, 33, 67, 100), "none" to "3 or more pads per day"(scores from 0 - 3, CSS:100, 67, 33, 0), "no problem" to "big problem"(scores from 0 - 4, CSS:100, 75, 50, 25, 0), and "no problem" to "big problem"(scores from 1 - 5, corresponding standardized score:100, 75, 50, 25, 0). Score from each answer was converted into a corresponding standardized score at each visit. Total score was calculated by taking average of standardized scores. Total score ranged from 0(worst) to 100(best), higher scores = better urinary function. | Baseline, months 6, 12, 18 and 24 |
| Change From Baseline in Memorial Anxiety Scale for Prostate Cancer (MAX-PC) Scores at Months 6, 12, 18 and 24 | The MAX-PC was a questionnaire used to assess participants' feelings about prostate cancer and PSA tests. There were a total of 18 questions related to understanding how participants cope with aspects of their treatment and medical tests frequently involved in their care; questions such as strong feelings about prostate cancer, scared of PSA tests, trouble sleeping due to thoughts of prostate cancer, unable to plan for the future due to prostate cancer, fear of cancer getting worse. The answers range from "not at all" to "often" and "strongly disagree" to "strongly agree. Total score ranged from 0-54, an increase in the score indicates a worsened anxiety level. | Baseline, months 6, 12, 18 and 24 |
| Homewood |
| Alabama |
| 35209 |
| United States |
| Site US10007 | Tucson | Arizona | 85704 | United States |
| Site US10055 | Tucson | Arizona | 85741 | United States |
| Site US10004 | Los Angeles | California | 90048 | United States |
| Site US10026 | Sacramento | California | 95670 | United States |
| Site US10010 | San Diego | California | 92123 | United States |
| Site US10051 | Aurora | Colorado | 80045 | United States |
| Site US10029 | Denver | Colorado | 80211 | United States |
| Site US10054 | Denver | Colorado | 80220 | United States |
| Site US10072 | Bradenton | Florida | 34205 | United States |
| Site US10057 | Lakeland | Florida | 33805 | United States |
| Site US10038 | Chicago | Illinois | 60611 | United States |
| Site US10062 | Chicago | Illinois | 60612 | United States |
| Site US10074 | Chicago | Illinois | 60612 | United States |
| Site US10018 | Glenview | Illinois | 60026 | United States |
| Site US10071 | Lake Barrington | Illinois | 60010 | United States |
| Site US10046 | Carmel | Indiana | 46033 | United States |
| Site US10009 | Jeffersonville | Indiana | 47130 | United States |
| Site US10037 | New Orleans | Louisiana | 70112 | United States |
| Site US10006 | Shreveport | Louisiana | 71106 | United States |
| Site US10001 | Towson | Maryland | 21204 | United States |
| Site US10032 | Boston | Massachusetts | 02111 | United States |
| Site US10008 | Troy | Michigan | 48084 | United States |
| Site US10069 | Lincoln | Nebraska | 68516 | United States |
| Site US10044 | Omaha | Nebraska | 68114 | United States |
| Site US10067 | Omaha | Nebraska | 68130 | United States |
| Site US10061 | Lebanon | New Hampshire | 03756 | United States |
| Site US10049 | Morristown | New Jersey | 07962 | United States |
| Site US10043 | Voorhees Township | New Jersey | 08043 | United States |
| Site US10068 | Brooklyn | New York | 11215 | United States |
| Site US10050 | Cheektowaga | New York | 14225 | United States |
| Site US10030 | Garden City | New York | 11530 | United States |
| Site US10028 | Poughkeepsie | New York | 12601 | United States |
| Site US10021 | Syracuse | New York | 13210 | United States |
| Site US10022 | Syracuse | New York | 13210 | United States |
| Site US10047 | Gastonia | North Carolina | 28053 | United States |
| Site US10045 | Cleveland | Ohio | 44195 | United States |
| Site US10015 | Middleburg Heights | Ohio | 44130 | United States |
| Site US10053 | Oklahoma City | Oklahoma | 73104 | United States |
| Site US10063 | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Site US10052 | Lancaster | Pennsylvania | 17604 | United States |
| Site US10014 | Warwick | Rhode Island | 02886 | United States |
| Site US10019 | Myrtle Beach | South Carolina | 29572 | United States |
| Site US10011 | Nashville | Tennessee | 37209 | United States |
| Site US10056 | Dallas | Texas | 75231 | United States |
| Site US10036 | Houston | Texas | 77027 | United States |
| Site US10035 | San Antonio | Texas | 78229 | United States |
| Site US10058 | Richmond | Virginia | 23235 | United States |
| Site US10017 | Milwaukee | Wisconsin | 53226 | United States |
| Site CA15005 | Abbotsford British Columbia | British Columbia | V2S 3N6 | Canada |
| Site CA15004 | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Site CA15001 | Toronto | Ontario | M4N3M5 | Canada |
| Site CA15003 | Toronto | Ontario | M5G2M9 | Canada |
| Ross AE, Iwata KK, Elsouda D, Hairston J, Russell D, Davicioni E, Proudfoot JA, Shore ND, Schaeffer EM. Transcriptome-Based Prognostic and Predictive Biomarker Analysis of ENACT: A Randomized Controlled Trial of Enzalutamide in Men Undergoing Active Surveillance. JCO Precis Oncol. 2024 Apr;8:e2300603. doi: 10.1200/PO.23.00603. |
| 35708696 | Derived | Shore ND, Renzulli J, Fleshner NE, Hollowell CMP, Vourganti S, Silberstein J, Siddiqui R, Hairston J, Elsouda D, Russell D, Cooperberg MR, Tomlins SA. Enzalutamide Monotherapy vs Active Surveillance in Patients With Low-risk or Intermediate-risk Localized Prostate Cancer: The ENACT Randomized Clinical Trial. JAMA Oncol. 2022 Aug 1;8(8):1128-1136. doi: 10.1001/jamaoncol.2022.1641. |
| Link to plain language summary of the study on the Trial Results Summaries website | View source |
| FG001 | Active Surveillance | The study has 3 parts: treatment period, 1 year follow-up period and continued follow-up period. Participants did not receive any study treatment in this arm but were on continued active surveillance (AS) for 1 year of treatment period. Following the 1-year treatment period, all participants were followed for 1 additional year. Post the 1-year follow up, participants then started the continued follow-up period, in which, participants were followed up every 3 months for these 2 years, after which follow-up was either every 6 months up to 36 months or until the end of study (total duration of follow up in the study was approximately up to 35.9 months). |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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The full analysis set (FAS) consisted of all participants who were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Enzalutamide | The study has 3 parts: treatment period, 1 year follow-up period and continued follow-up period. Participants received 160-mg enzalutamide administered as four 40-mg capsules, orally once daily for 1 year of treatment period. Following the 1-year treatment period, all participants were followed for 1 additional year. Post the 1-year follow-up period, participants then started the continued follow-up period, in which, participants were followed up every 3 months for these 2 years, after which follow-up was either every 6 months up to 36 months or until the end of study (total duration of follow up in the study was approximately up to 35.9 months). |
| BG001 | Active Surveillance | The study has 3 parts: treatment period, 1 year follow-up period and continued follow-up period. Participants did not receive any study treatment in this arm but were on continued AS for 1 year of treatment period. Following the 1-year treatment period, all participants were followed for 1 additional year. Post the 1-year follow up, participants then started the continued follow-up period, in which, participants were followed up every 3 months for these 2 years, after which follow-up was either every 6 months up to 36 months or until the end of study (total duration of follow up in the study was approximately up to 35.9 months). |
| BG002 | Total | Total of all reporting groups |
| 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type of Biopsy | Type of biopsies included: 1. mpMRI (multiparametric magnetic resonance imaging) type, 2. non-mpMRI type. | Count of Participants | Participants |
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| Prostate Cancer Risk | Low risk:no higher than T1c-T2a, prostate specific antigen(PSA)<10,N0,M0(or presumed N0,M0 if computerized tomography[CT]/bone scan not done due to low risk of metastases),gleason score(GS)<=6,eastern cooperative oncology group(ECOG)status<= 2, life expectancy>5years. Intermediate risk:no higher than T2b-T2c, PSA<20, N0, M0(or presumed N0, M0 if CT/bone scan not done), GS<=7(3+4 pattern only),ECOG status<=2, life expectancy>5 years. No primary GS 4 was allowed. T1c-T2a, T2b-T2c:Clinical tumor Stages at initial diagnosis; N0:Clinical lymph node stage at initial diagnosis; M0:Distant metastasis. | Count of Participants | Participants |
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| 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 | Time to Prostate Cancer Progression | Time to cancer prostate progression (pathological or therapeutic): time (in months) from date of randomization until the date of cancer progression (pathological or therapeutic). Pathological progression: increase in primary or secondary Gleason pattern by greater than or equal (>=) 1 or higher proportion of cancer positive cores (>=15 percent [%] increase). Therapeutic progression: earliest occurrence of primary therapy for prostate cancer (prostatectomy/radiation/focal therapy/systemic therapy). Medians and 95% CIs were calculated with the Kaplan-Meier (KM) method. Participants with no cancer progression at the time of study completion, discontinuation or death were censored at the last assessment date. Participants switching therapy during the study were censored at the time of the initial therapy switch, and participants discontinuing therapy were censored at the time of study discontinuation. | FAS population | Posted | Median | 95% Confidence Interval | Months | From the date of randomization until the date of the cancer progression (pathological or therapeutic) (up to study completion date, 28 Aug 2020; approximately 50 months) |
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| Secondary | Number of Participants With Adverse Events (AEs) | An AE: any untoward medical occurrence in a participant administered study drug or who underwent study procedures and did not necessarily had a causal relationship with treatment. An abnormality identified during a medical test: an AE only if the abnormality induced clinical signs or symptoms, required active intervention, required interruption, or discontinuation of study medication, or was clinically significant in the opinion of investigator. An AE: serious if it resulted in any of the following outcomes: Death, was life-threatening, Persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, Congenital anomaly, or birth defect, Inpatient hospitalization or prolongation of hospitalization, Other medically important event. Drug-related AEs: assessed by investigator as AEs whose relationship to study drugs could not be ruled out. | The safety analysis set (SAF) consisted of all participants who enrolled in the study and were randomized to receive study drug. | Posted | Count of Participants | Participants | From date of first dose of enzalutamide or randomization until end of study (up to study completion date, 28 Aug 2020; approximately 50 months) |
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| Secondary | Percentage of Participants Reported Negative Biopsies for Cancer | Percentage of Participants who reported negative biopsies for cancer were reported. | FAS population with available data at each time point. | Posted | Number | Percentage of participants | At the end of months 12 and 24 |
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| Secondary | Change From Baseline in Percent of Cancer Positive Cores at Month 12 and 24 | Percent positive cores were calculated using the number of systemically sampled prostate regions and any targeted regions with at least 1 positive core divided by the total number of systematically sampled regions and targeted regions. This implied that despite the number of samples within a given systematic or targeted region, any positive core indicated that region as positive. | FAS population with available data at each time point. | Posted | Mean | Standard Deviation | Percent of Cancer positive cores | Baseline, months 12 and 24 |
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| Secondary | Time to Prostate-specific Antigen (PSA) Progression | Time to PSA progression was defined as time in months from the date of randomization or first dose enzalutamide untill date of PSA progression (secondary rise in serum PSA >=25% above baseline or >=25% above nadir or absolute increase >= 2 nanogram per mililiter [ng/mL]). Participants with no PSA progression at the time of trial completion, discontinuation or death were censored at the last assessment date. Additionally, participants switching therapy during the study were censored at the time of the initial therapy switch, and participants discontinuing therapy were censored at the time of study discontinuation. Medians and 95% CIs were calculated with the KM method. | FAS population | Posted | Median | 95% Confidence Interval | Months | From date of randomization or first dose of enzalutamide until date of PSA progression (pathological or therapeutic) (up to study completion date=28 Aug 2020, median duration: 14.82 months for "Enzalutamide", 8.80 months for "Active Surveillance") |
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| Secondary | Percentage of Participants With Secondary Rise in Serum PSA | Percentage of participants with secondary rise in serum PSA > 25% baseline or > 25% above nadir or absolute increase >2 ng/mL were reported in this measure. | FAS population with available data at each time point. | Posted | Number | Percentage of participants | At the end of months 12, 24 and at the end of study (up to study completion date, 28 Aug 2020, approximately 50 months) |
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| Secondary | Change From Baseline in Brief Fatigue Inventory (BFI) Questionnaire Composite Scores to Months 3, 6, 12, 18 and 24 | The BFI is a screening tool designed to assess the severity and impact of fatigue on daily functioning of participants with cancer during the 24 hours. There are 9 items on the scale. The first three questions ask participants to rate their fatigues on a scale from 0 (no fatigue) - 10 (as bad as you can imagine), with higher scores indicating worse outcome. The remaining six questions ask participants to rate how much fatigue has interfered with their daily activities on a scale from 0 (Does not interfere) to 10 (Completely interferes). A composite fatigue score was obtained by averaging all the items on the BFI, ranged between 0 to 10, with a higher BFI fatigue score indicating worse outcome. The composite BFI score was calculated only if at least 5 of the 9 items were answered. | FAS population with available data at each time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, months 3, 6, 12, 18 and 24 |
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| Secondary | Change From Baseline in 12-Item Short Form Survey (SF-12) Questionnaire Composite Score to Months 6, 12, 18, 24 - Mental Component Summary | SF-12 is a questionnaire that measures overall health related quality of life using 12 questions. The questions are then scored and weighted into 2 subscales, physical health and mental health. Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life). Scores are transformed and ranges between 0 to 100; higher score indicates improvement. | FAS population with available data at each time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, months 6, 12, 18 and 24 |
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| Secondary | Change From Baseline in SF-12 Questionnaire Composite Score to Months 6, 12, 18, 24 - Physical Component Summary | SF-12 is a questionnaire that measures overall health related quality of life using 12 questions. The questions are then scored and weighted into 2 subscales, physical health and mental health. Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life). Scores are transformed and ranges between 0 to 100; higher score indicates improvement. | FAS population with available data at each time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, months 6, 12, 18 and 24 |
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| Secondary | Change From Baseline in The Expanded Prostate Cancer Index Composite (EPIC) Hormonal Assessment Scores at Months 6, 12, 18 and 24 | The EPIC Hormonal Assessment was a questionnaire used to measure quality of life (QoL) issues in participants with prostate cancer. There were a total of 6 questions related to hormonal function such as hot flashes, breast tenderness, depression, lack of energy, weight fluctuation. The answers ranged from "more than once a day" to "rarely or never" (ranged from 1 to 5, corresponding standardized scores were 100, 75, 50, 25, 0), "no problem" to "big problem" (ranged from 0 to 4, corresponding standardized scores were 100, 75, 50, 25, 0). Score from each answer was converted into standardized score at each visit. Total score was calculated by taking average of standardized scores. Total score was measured on a scale ranged from 0 (worst) to 100 (best) scale with higher scores representing better hormonal function. | FAS population with available data at each time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, months 6, 12, 18 and 24 |
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| Secondary | Change From Baseline in EPIC Sexual Assessment Scores at Months 6, 12, 18 and 24 | EPIC Sexual Assessment: a questionnaire to measure QoL issues in participants with prostate cancer, included a total of 9 questions on sexual function as level of sexual desire, ability to have an erection, ability to reach orgasm, quality and frequency of erections, frequency of sexual intercourse. Answers ranged from "very poor" to "very good,"(ranged from 1 - 5, corresponding standardized scores:0, 25, 50, 75, 100), "none" to "enough"(ranged from 1 - 4, corresponding standardized scores:0, 33, 67, 100), "no problem" to "big problem"(ranged from 0 - 4, corresponding standardized scores:100, 75, 50, 25, 0), and "never" to "daily"(ranged from 1 - 5, corresponding standardized scores:100, 75, 50, 25, 0). Scores from each answer was converted into standardized score at each visit. Total score = calculated by taking average of standardized scores. Total score was measured on a scale ranged from 0 (worst) to 100 (best), higher scores = better sexual function and satisfaction. | FAS population with available data at each time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, months 6, 12, 18 and 24 |
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| Secondary | Change From Baseline in EPIC Urinary Assessment Scores at Month 6, 12, 18 and 24 | EPIC urinary assessment: a questionnaire to measure QoL issues in participants with prostate cancer, included a total of 7 questions on urinary function as leaking urine, blood in urine, pain/burning on urination, urinary control and frequency. Answers ranged from "more than once a day" to "rarely or never"(scores from 1 - 5,corresponding standardized scores[CSS]:0, 25, 50, 75, 100), "no urinary control" to "full urinary control"(scores from 1 - 4,CSS:0, 33, 67, 100), "none" to "3 or more pads per day"(scores from 0 - 3, CSS:100, 67, 33, 0), "no problem" to "big problem"(scores from 0 - 4, CSS:100, 75, 50, 25, 0), and "no problem" to "big problem"(scores from 1 - 5, corresponding standardized score:100, 75, 50, 25, 0). Score from each answer was converted into a corresponding standardized score at each visit. Total score was calculated by taking average of standardized scores. Total score ranged from 0(worst) to 100(best), higher scores = better urinary function. | FAS population with available data at each time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, months 6, 12, 18 and 24 |
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| Secondary | Change From Baseline in Memorial Anxiety Scale for Prostate Cancer (MAX-PC) Scores at Months 6, 12, 18 and 24 | The MAX-PC was a questionnaire used to assess participants' feelings about prostate cancer and PSA tests. There were a total of 18 questions related to understanding how participants cope with aspects of their treatment and medical tests frequently involved in their care; questions such as strong feelings about prostate cancer, scared of PSA tests, trouble sleeping due to thoughts of prostate cancer, unable to plan for the future due to prostate cancer, fear of cancer getting worse. The answers range from "not at all" to "often" and "strongly disagree" to "strongly agree. Total score ranged from 0-54, an increase in the score indicates a worsened anxiety level. | FAS population with available data at each time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, months 6, 12, 18 and 24 |
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From date of first dose of enzalutamide or randomization until end of study (up to study completion date, 28 Aug 2020, approximately 50 months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enzalutamide | The study has 3 parts: treatment period, 1 year follow-up period and continued follow-up period. Participants received 160-mg enzalutamide administered as four 40-mg capsules, orally once daily for 1 year of treatment period. Following the 1-year treatment period, all participants were followed for 1 additional year. Post the 1-year follow-up period, participants then started the continued follow-up period, in which, participants were followed up every 3 months for these 2 years, after which follow-up was either every 6 months up to 36 months or until the end of study (total duration of follow up in the study was approximately up to 35.9 months). | 3 | 112 | 19 | 112 | 101 | 112 |
| EG001 | Active Surveillance | The study has 3 parts: treatment period, 1 year follow-up period and continued follow-up period. Participants did not receive any study treatment in this arm but were on continued AS for 1 year of treatment period. Following the 1-year treatment period, all participants were followed for 1 additional year. Post the 1-year follow up, participants then started the continued follow-up period, in which, participants were followed up every 3 months for these 2 years, after which follow-up was either every 6 months up to 36 months or until the end of study (total duration of follow up in the study was approximately up to 35.9 months). | 0 | 113 | 10 | 113 | 34 | 113 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Arteriospasm coronary | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Coronary artery perforation | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Accidental death | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Central cord syndrome | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| Electroencephalogram abnormal | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Movement disorder | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Physical disability | Social circumstances | MedDRA v23.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Breast enlargement | Reproductive system and breast disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Breast tenderness | Reproductive system and breast disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Nipple pain | Reproductive system and breast disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v23.0 | Systematic Assessment |
|
Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure | Astellas Pharma Global Development, Inc. | 800-888-7704 | astellas.resultsdisclosure@astellas.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 16, 2020 | Oct 14, 2021 | SAP_001.pdf |
| 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 |
|---|---|
| C540278 | enzalutamide |
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| non-mpMRI-targeted |
|
| Intermediate |
|
| OG001 | Active Surveillance | The study has 3 parts: treatment period, 1 year follow-up period and continued follow-up period. Participants did not receive any study treatment in this arm but were on continued AS for 1 year of treatment period. Following the 1-year treatment period, all participants were followed for 1 additional year. Post the 1-year follow up, participants then started the continued follow-up period, in which, participants were followed up every 3 months for these 2 years, after which follow-up was either every 6 months up to 36 months or until the end of study (total duration of follow up in the study was approximately up to 35.9 months). |
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|
| OG001 | Active Surveillance | The study has 3 parts: treatment period, 1 year follow-up period and continued follow-up period. Participants did not receive any study treatment in this arm but were on continued AS for 1 year of treatment period. Following the 1-year treatment period, all participants were followed for 1 additional year. Post the 1-year follow up, participants then started the continued follow-up period, in which, participants were followed up every 3 months for these 2 years, after which follow-up was either every 6 months up to 36 months or until the end of study (total duration of follow up in the study was approximately up to 35.9 months). |
|
|
|
|
|
|
| OG001 | Active Surveillance | The study has 3 parts: treatment period, 1 year follow-up period and continued follow-up period. Participants did not receive any study treatment in this arm but were on continued AS for 1 year of treatment period. Following the 1-year treatment period, all participants were followed for 1 additional year. Post the 1-year follow up, participants then started the continued follow-up period, in which, participants were followed up every 3 months for these 2 years, after which follow-up was either every 6 months up to 36 months or until the end of study (total duration of follow up in the study was approximately up to 35.9 months). |
|
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|
|
|
|
| OG001 | Active Surveillance | The study has 3 parts: treatment period, 1 year follow-up period and continued follow-up period. Participants did not receive any study treatment in this arm but were on continued AS for 1 year of treatment period. Following the 1-year treatment period, all participants were followed for 1 additional year. Post the 1-year follow up, participants then started the continued follow-up period, in which, participants were followed up every 3 months for these 2 years, after which follow-up was either every 6 months up to 36 months or until the end of study (total duration of follow up in the study was approximately up to 35.9 months). |
|
|
| OG001 | Active Surveillance | The study has 3 parts: treatment period, 1 year follow-up period and continued follow-up period. Participants did not receive any study treatment in this arm but were on continued AS for 1 year of treatment period. Following the 1-year treatment period, all participants were followed for 1 additional year. Post the 1-year follow up, participants then started the continued follow-up period, in which, participants were followed up every 3 months for these 2 years, after which follow-up was either every 6 months up to 36 months or until the end of study (total duration of follow up in the study was approximately up to 35.9 months). |
|
|
| OG001 | Active Surveillance | The study has 3 parts: treatment period, 1 year follow-up period and continued follow-up period. Participants did not receive any study treatment in this arm but were on continued AS for 1 year of treatment period. Following the 1-year treatment period, all participants were followed for 1 additional year. Post the 1-year follow up, participants then started the continued follow-up period, in which, participants were followed up every 3 months for these 2 years, after which follow-up was either every 6 months up to 36 months or until the end of study (total duration of follow up in the study was approximately up to 35.9 months). |
|
|
| OG001 |
| Active Surveillance |
The study has 3 parts: treatment period, 1 year follow-up period and continued follow-up period. Participants did not receive any study treatment in this arm but were on continued AS for 1 year of treatment period. Following the 1-year treatment period, all participants were followed for 1 additional year. Post the 1-year follow up, participants then started the continued follow-up period, in which, participants were followed up every 3 months for these 2 years, after which follow-up was either every 6 months up to 36 months or until the end of study (total duration of follow up in the study was approximately up to 35.9 months). |
|
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