NCT02918968 is a Phase 4 clinical trial of Enzalutamide in Prostate Cancer, sponsored by Astellas Pharma Inc.

Who is sponsoring NCT02918968?

NCT02918968 is sponsored by Astellas Pharma Inc.

What drugs are being tested in NCT02918968?

Interventions in NCT02918968: Enzalutamide, Flutamide, Androgen deprivation therapy.

What condition does NCT02918968 study?

NCT02918968 studies Prostate Cancer.

Is NCT02918968 still recruiting?

NCT02918968 is currently completed. Last updated 9 December 2024.

Are results published for NCT02918968?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-12-09 · How we verify

NCT02918968

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study on Enzalutamide and Flutamide in Patients With Castration Resistant Prostate Cancer

Completed Phase 4 Results posted Last updated 9 December 2024

What this trial tests

Phase 4 trial testing Enzalutamide in Prostate Cancer in 206 participants. Completed in 27 March 2020.

Timeline

2 November 2016

Primary endpoint
27 March 2020

27 March 2020

Quick facts

Lead sponsor	Astellas Pharma Inc
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	206
Start date	2 November 2016
Primary completion	27 March 2020
Estimated completion	27 March 2020
Sites	47 locations across Japan

Drugs / interventions tested

Enzalutamide (enzalutamide) — full drug profile →
Flutamide (flutamide) — full drug profile →
Androgen deprivation therapy — full drug profile →

Conditions studied

Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Astellas Pharma Inc — full company profile →

Who can join

20 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time to PSA Progression With 1st Line AAT (TTPP1) Primary · From date of randomization to the date of PSA progression in the 1st line AAT period (Up to 38 months)

TTPP1 was defined as the period from the date of randomization to the date of PSA progression in the 1st line AAT period. PSA progression was defined according to the consensus guidelines of prostate cancer clinical trials working group 2 (PCWG2). For participants with PSA declines at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir were documented, which was confirmed by a second consecutive value obtained 3 or more weeks later. For participants with no PSA decline at week 13, the PSA progression date was def

Group	Value	95% CI
Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT	21.39	12.16 – NA
Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT	5.78	4.67 – 8.54

Time to PSA Progression With 2nd Line AAT (TTPP2) Secondary · From date of randomization to the date of PSA progression in 2nd line AAT (Up to 38 months)

TTPP2 was defined as the period from day 1 of the 2nd line AAT to the date of PSA progression with the 2nd line AAT. PSA progression was defined according to the consensus guidelines of PCWG2. For participants with PSA declines at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir were documented, which was confirmed by a second consecutive value obtained 3 or more weeks later. For participants with no PSA decline at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute

Group	Value	95% CI
Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT	NA	20.99 – NA
Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT	21.22	14.78 – NA

Percentage of Participants Achieving at Least 50 or 90 Percent (%) Reduction From Baseline and Up To Week 38 in Prostate Specific Antigen (PSA) Response at 1st Line AAT Secondary · Baseline and at least 3 weeks after, the lowest PSA decreased by at least 50% or 90% from baseline (Up to 38 months)

PSA response was defined as PSA decreased by at least 50% or 90% from baseline when at least 3 weeks passed after the lowest PSA decreased by at least 50% or 90% from baseline in the 1st line AAT period after baseline. Data was reported per each disease stage (M0/N0, M0/N1, M1). 1) M0/N0: No distant metastasis and no lymph node metastasis. 2) M0/N1: Without distant metastasis, but with metastasis in lymph nodes distal to the aortic bifurcation. 3) M1: With distant metastasis (including metastasis in lymph nodes proximal to the aortic bifurcation).

M0/N0: (≥ 50% reduction)

Group	Value	95% CI
Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT	75.0	53.3 – 90.2
Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT	48.0	27.8 – 68.7

M0/N1: (≥ 50% reduction)

Group	Value	95% CI
Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT	66.7	9.4 – 99.2
Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT	0.0	0.0 – 60.2

M1: (≥ 50% reduction)

Group	Value	95% CI
Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT	72.0	60.4 – 81.8
Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT	32.0	21.7 – 43.8

All participants: (≥ 50% reduction)

Group	Value	95% CI
Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT	72.5	62.8 – 80.9
Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT	34.6	25.6 – 44.6

M0/N0: (≥ 90% reduction)

Group	Value	95% CI
Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT	62.5	40.6 – 81.2
Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT	8.0	1.0 – 26.0

M0/N1: (≥ 90% reduction)

Group	Value	95% CI
Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT	33.3	0.8 – 90.6
Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT	0.0	0.0 – 60.2

M1: (≥ 90% reduction)

Group	Value	95% CI
Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT	53.3	41.4 – 64.9
Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT	20.0	11.6 – 30.8

All participants: (≥ 90% reduction)

Group	Value	95% CI
Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT	54.9	44.7 – 64.8
Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT	16.3	9.8 – 24.9

Percentage of Participants Achieving at Least 50 or 90 Percent (%) Reduction From Baseline to Week 13 in Prostate Specific Antigen (PSA) Response at 1st Line AAT Secondary · Baseline and week 13

PSA response was defined as the lowest PSA at week 13 decreased by at least 50% or 90% from baseline in the 1st line AAT period. Data was reported per each disease stage (M0/N0, M0/N1, M1). 1) M0/N0: No distant metastasis and no lymph node metastasis. 2) M0/N1: Without distant metastasis, but with metastasis in lymph nodes distal to the aortic bifurcation. 3) M1: With distant metastasis (including metastasis in lymph nodes proximal to the aortic bifurcation).

M0/N0: (≥ 50% reduction)

Group	Value	95% CI
Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT	83.3	62.6 – 95.3
Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT	40.0	21.1 – 61.3

M0/N1: (≥ 50% reduction)

Group	Value	95% CI
Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT	66.7	9.4 – 99.2
Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT	0.0	0.0 – 60.2

M1: (≥ 50% reduction)

Group	Value	95% CI
Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT	72.0	60.4 – 81.8
Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT	33.3	22.9 – 45.2

All participants: (≥ 50% reduction)

Group	Value	95% CI
Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT	74.5	64.9 – 82.6
Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT	33.7	24.7 – 43.6

M0/N0: (≥ 90% reduction)

Group	Value	95% CI
Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT	50.0	29.1 – 70.9
Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT	8.0	1.0 – 26.0

M0/N1: (≥ 90% reduction)

Group	Value	95% CI
Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT	33.3	0.8 – 90.6
Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT	0.0	0.0 – 60.2

M1: (≥ 90% reduction)

Group	Value	95% CI
Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT	49.3	37.6 – 61.1
Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT	18.7	10.6 – 29.3

All participants: (≥ 90% reduction)

Group	Value	95% CI
Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT	49.0	39.0 – 59.1
Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT	15.4	9.1 – 23.8

Time to PSA Decrease by 50% From Baseline With 1st Line AAT Secondary · From date of randomization to the day when the decrease of PSA from baseline by 50% is first identified (Up to 38 months)

Time to PSA decrease by 50% with 1st line AAT was defined as the period from the date of randomization to the day when the decrease of PSA from baseline by 50% is first identified. Time to event analysis was performed using kaplan-meier estimates. Data was reported per each disease stage (M0/N0, M0/N1, M1). 1) M0/N0: No distant metastasis and no lymph node metastasis. 2) M0/N1: Without distant metastasis, but with metastasis in lymph nodes distal to the aortic bifurcation. 3) M1: With distant metastasis (including metastasis in lymph nodes proximal to the aortic bifurcation).

M0/N0

Group	Value	95% CI
Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT	2.79	2.66 – 3.02
Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT	3.94	2.79 – NA

M0/N1

Group	Value	95% CI
Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT	2.79	2.56 – NA
Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT	NA	NA – NA

Group	Value	95% CI
Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT	2.79	NA – NA
Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT	7.49	3.02 – NA

Time to Treatment Failure of 1st Line AAT (TTF1) Secondary · From date of randomization to discontinuation of 1st line AAT (Up to 38 months)

TTF1 was defined as the period from randomization to study drug discontinuation of 1st line AAT for any reason that includes disease progression, onset of adverse events (AEs), participants request, or death. Time to event analysis was performed using kaplan-meier estimates. Data was reported per each disease stage (M0/N0, M0/N1, M1). 1) M0/N0: No distant metastasis and no lymph node metastasis. 2) M0/N1: Without distant metastasis, but with metastasis in lymph nodes distal to the aortic bifurcation. 3) M1: With distant metastasis (including metastasis in lymph nodes proximal to the aortic bi

M0/N0

Group	Value	95% CI
Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT	17.58	10.15 – 24.11
Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT	7.72	4.47 – 15.67

M0/N1

Group	Value	95% CI
Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT	5.55	4.86 – 10.38
Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT	4.73	1.87 – 7.62

Group	Value	95% CI
Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT	12.02	7.39 – 18.43
Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT	3.94	3.65 – 5.55

Time to Treatment Failure of 2nd Line AAT (TTF2) Secondary · From date of randomization to discontinuation of 2nd line AAT (Up to 38 months)

TTF2 was defined as the period from randomization to study drug discontinuation of 2nd line AAT for any reason that includes disease progression, onset of AEs, participants request, or death. Time to event analysis was performed using kaplan-meier estimates.

Group	Value	95% CI
Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT	23.03	16.79 – NA
Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT	16.59	13.14 – 23.95

Radiographic Progression-free Survival (rPFS) Secondary · From date of randomization to the time when radiographic disease progression is observed or death of any cause (up to 38 months)

rPFS was defined as the period from randomization to the time when radiographic disease progression is observed or death of any cause during the study period, whichever occurs earlier. Time to event analysis was performed using kaplan-meier estimates. Data was reported per each disease stage (M0/N0, M0/N1, M1). 1) M0/N0: No distant metastasis and no lymph node metastasis. 2) M0/N1: Without distant metastasis, but with metastasis in lymph nodes distal to the aortic bifurcation. 3) M1: With distant metastasis (including metastasis in lymph nodes proximal to the aortic bifurcation).

Group	Value	95% CI
Enzalutamide 160 mg 1st Line AAT/Flutamide 375 mg 2nd Line AAT	NA	NA – NA
Flutamide 375 mg 1st Line AAT/Enzaltumide 160 mg 2nd Line AAT	NA	29.08 – NA

Adverse events — posted to ClinicalTrials.gov

Time frame: From of date of randomization to end of study (up to 38 months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Enzalutamide 160mg 1st Line AAT

Serious: 29/102 (28%)

Deaths: 1/102

Enzalutamide 160mg 2nd Line AAT

Serious: 18/85 (21%)

Deaths: 1/85

Flutamide 375mg 1st Line AAT

Serious: 15/104 (14%)

Deaths: 0/104

Flutamide 375mg 2nd Line AAT

Serious: 4/48 (8%)

Deaths: 0/48

Serious adverse events (81 terms)

Reaction	System	Enzalutamide 160mg 1st Lin…	Enzalutamide 160mg 2nd Lin…	Flutamide 375mg 1st Line AAT	Flutamide 375mg 2nd Line AAT
Cerebral infarction	Nervous system disorders	—	—	—	—
Large intestine polyp	Gastrointestinal disorders	—	—	—	—
Hepatic function abnormal	Hepatobiliary disorders	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—
Spinal compression fracture	Injury, poisoning and procedural complications	—	—	—	—
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Pancytopenia	Blood and lymphatic system disorders	—	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—	—
Angina pectoris	Cardiac disorders	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—
Cardiac failure	Cardiac disorders	—	—	—	—
Cardiac failure acute	Cardiac disorders	—	—	—	—
Coronary artery stenosis	Cardiac disorders	—	—	—	—
Cataract	Eye disorders	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—
Diverticulum intestinal	Gastrointestinal disorders	—	—	—	—
Gastric ulcer haemorrhage	Gastrointestinal disorders	—	—	—	—
Ileus paralytic	Gastrointestinal disorders	—	—	—	—
Inguinal hernia	Gastrointestinal disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Liver disorder	Hepatobiliary disorders	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—
Enterocolitis bacterial	Infections and infestations	—	—	—	—

Other adverse events (21 terms — click to expand)

Reaction	System	Enzalutamide 160mg 1st Lin…	Enzalutamide 160mg 2nd Lin…	Flutamide 375mg 1st Line AAT	Flutamide 375mg 2nd Line AAT
Nasopharyngitis	Infections and infestations	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—
Malaise	General disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—
Hepatic function abnormal	Hepatobiliary disorders	—	—	—	—
Dental caries	Gastrointestinal disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Influenza	Infections and infestations	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—
Spinal compression fracture	Injury, poisoning and procedural complications	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Haematuria	Renal and urinary disorders	—	—	—	—
Hot flush	Vascular disorders	—	—	—	—
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—

Most-reported serious reactions: Cerebral infarction, Large intestine polyp, Hepatic function abnormal, Pneumonia, Spinal compression fracture, Cancer pain, Lung neoplasm malignant, Anaemia.

Data from ClinicalTrials.gov NCT02918968 adverse events section.

Sponsor's own description

The objective of this study was to compare the efficacy and safety of the combination therapy with enzalutamide + androgen deprivation therapy (ADT) and the combination therapy with flutamide + ADT in patients with castration resistant prostate cancer who had relapsed during combined androgen blockade (CAB) therapy with bicalutamide and ADT. This study also investigated the order of alternative antiandrogen therapy (AAT) by changing the 1st line medication after relapse of prostate-specific antigen (PSA).

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

ARe we there yet? Understanding androgen receptor signaling in breast cancer.
Michmerhuizen AR, Spratt DE, Pierce LJ, Speers CW. · · 2020 · cited 82× · PMID 33062889 · DOI 10.1038/s41523-020-00190-9
Enzalutamide versus flutamide for castration-resistant prostate cancer after combined androgen blockade therapy with bicalutamide: study protocol for a multicenter randomized phase II trial (the OCUU-CRPC study).
Iguchi T, Tamada S, Kato M, Yasuda S, et al · · 2019 · cited 13× · PMID 30971225 · DOI 10.1186/s12885-019-5526-3
Enzalutamide + androgen deprivation therapy (ADT) versus flutamide + ADT in Japanese men with castration-resistant prostate cancer: AFTERCAB study.
Uemura H, Kobayashi K, Yokomizo A, Hinotsu S, et al · · 2022 · cited 8× · PMID 35475157 · DOI 10.1002/bco2.103
The androgen receptor-targeted proteolysis targeting chimera and other alternative therapeutic choices in overcoming the resistance to androgen deprivation treatment in prostate cancer.
Li L, Xu J. · · 2023 · cited 5× · PMID 36203075 · DOI 10.1007/s12094-022-02957-x
Identification of favorable subgroups for alternative anti-androgen therapy in castration-resistant prostate cancer.
Suzuki K, Terakawa T, Shigemura K, Furukawa J, et al · · 2019 · cited 4× · PMID 31620284 · DOI 10.3892/mco.2019.1915
Health-related quality of life with enzalutamide versus flutamide in castration-resistant prostate cancer from the AFTERCAB study.
Uemura H, Kobayashi K, Yokomizo A, Hinotsu S, et al · · 2022 · cited 3× · PMID 35948732 · DOI 10.1007/s10147-022-02221-w
Evolving Treatments and Resistance Mechanisms in Prostate Cancer Therapeutics.
Sai Rishma Reddy GSV, Kumar A, Sharma NK, Samanta K, et al · · 2026 · PMID 41988377 · DOI 10.1021/acsptsci.5c00757

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02918968 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Astellas Pharma Inc
Last refreshed: 9 December 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02918968.

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