NCT02203695 is a Phase 2 clinical trial of Enzalutamide in Adenocarcinoma of the Prostate, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Who is sponsoring NCT02203695?

NCT02203695 is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

What drugs are being tested in NCT02203695?

Interventions in NCT02203695: Enzalutamide, SRT.

What condition does NCT02203695 study?

NCT02203695 studies Adenocarcinoma of the Prostate.

Is NCT02203695 still recruiting?

NCT02203695 is currently completed. Last updated 28 October 2025.

Are results published for NCT02203695?

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

Last reviewed 2025-10-28 · How we verify

NCT02203695

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

Randomized Salvage Radiation Therapy Plus Enzalutamide Post Prostatectomy

Completed Phase 2 Results posted Last updated 28 October 2025

What this trial tests

Phase 2 trial testing Enzalutamide in Adenocarcinoma of the Prostate in 86 participants. Completed in 31 December 2022.

Timeline

28 March 2015

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	86
Start date	28 March 2015
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	9 locations across United States

Drugs / interventions tested

Enzalutamide (enzalutamide) — full drug profile →
SRT

Conditions studied

Adenocarcinoma of the Prostate — all drugs for Adenocarcinoma of the Prostate →

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →

Who can join

Adults 18 to 100, male only, with Adenocarcinoma of the Prostate. 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.

Percent of Participants With Freedom of PSA (Prostate Specific Antigen) Progression Primary · From time of randomization to date of PSA progression, approximately 2 years.

The primary efficacy endpoint is the rate of Freedom-from-PSA-progression (FFPP) at 2-years. FFPP is defined as the time from randomization to the date of PSA progression. A subject who does not have PSA progression at the time of the analysis will be censored at the last date of PSA measurement.

Group	Value	95% CI
SRT Plus Enzalutamide	84
SRT Plus Placebo	66

Number of Participants With Local Recurrence Secondary · 2 years from end of radiation therapy

Local recurrence within the radiation field (confirmed pathologically) at 2-years

Group	Value	95% CI
SRT Plus Enzalutamide	0
SRT Plus Placebo	0

Metastatic Free Survival Rate Secondary · 2 years from the time of registration

Metastasis-free survival (MFS) rates at 2 years. Metastasis-free survival will be defined as the time from the date of registration to date of evidence of systemic disease on bone scan or cross sectional imaging or death, which occurs first. Number of participants with a metastasis event at 2 years is reported.

Group	Value	95% CI
SRT Plus Enzalutamide	0
SRT Plus Placebo	1

How Well Participants Tolerate Treatment Assessed by European Organization for Research & Treatment of Cancer Quality of Life (Questionnaire (EORTC-QLQ-P25) Secondary · Baseline, End of Treatment (180 Days) and 6 Months Post-treatment

The European Organization for the Research and Treatment of Cancer (EORTC-QLQ-P25) quality of life questionnaire, Prostate Cancer Module. Uses a 4-point Likert scale, with responses ranging from "not at all" to "very much" for sexual symptoms and treatment related symptoms. Domain scores range 0 to 100, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual).

Baseline-Sexual Symptoms

Group	Value	95% CI
SRT Plus Enzalutamide	53.70	± 44.56
SRT Plus Placebo	41.67	± 10.39

End of Treatment (180 days) -Sexual Symptoms

Group	Value	95% CI
SRT Plus Enzalutamide	59.72	± 38.32
SRT Plus Placebo	42.22	± 11.52

6 Months Post-treatment-Sexual Symptoms

Group	Value	95% CI
SRT Plus Enzalutamide	35.19	± 22.45
SRT Plus Placebo	35.19	± 3.21

Baseline-Treatment related Symptoms

Group	Value	95% CI
SRT Plus Enzalutamide	9.09	± 24.85
SRT Plus Placebo	4.04	± 3.59

End of treatment (180 days) -Treatment related Symptoms

Group	Value	95% CI
SRT Plus Enzalutamide	14.44	± 8.77
SRT Plus Placebo	3.09	± 2.92

6 Months Post-treatment-Treatment Related Symptoms

Group	Value	95% CI
SRT Plus Enzalutamide	11.11	± 6.42
SRT Plus Placebo	1.39	± 2.78

How Well Participants Tolerate Treatment Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P). Secondary · Baseline, End of Treatment (180 Days) and 6 Months Post-treatment

The Functional Assessment of Cancer Therapy (FACT-P), assesses the health-related quality of life in men with prostate cancer. The score is the sum of all 5 domain scores and ranges from 0 to156 where higher scores represent better quality of life.

Baseline

Group	Value	95% CI
SRT Plus Enzalutamide	126.15	± 13.06
SRT Plus Placebo	129	± 15.54

End of Treament (180 Days)

Group	Value	95% CI
SRT Plus Enzalutamide	123.40	± 12.02
SRT Plus Placebo	124.33	± 21.90

6 months Post-Treament

Group	Value	95% CI
SRT Plus Enzalutamide	126.86	± 13.69
SRT Plus Placebo	137.25	± 4.03

How Well Participants Tolerate Treatment Assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Secondary · Baseline, End of Treatment (180 Days) and 6 Months Post-treatment

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire score range is from 0 to 100. A higher score indicates a better level of functioning or quality of life.

Baseline-Physical Functioning

Group	Value	95% CI
SRT Plus Enzalutamide	92.22	± 10.68
SRT Plus Placebo	100.	± 0.00

End of Treatment - (180 Days) Physical Functioning

Group	Value	95% CI
SRT Plus Enzalutamide	95.33	± 8.92
SRT Plus Placebo	97.04	± 6.76

6 Months Post-treatment - Physical Functioning

Group	Value	95% CI
SRT Plus Enzalutamide	92.22	± 10.68
SRT Plus Placebo	100.	± 0.00

How Well Participants Tolerate Treatment Assessed by Sexual Health Inventory in Men (SHIM) Questionnaire. Secondary · Baseline, End of Treatment (180 Days) and 6 Months Post-treatment

Quality of life (QoL) tool used to determine participant tolerability of treatment assessed by Sexual Health inventory in Men (SHIM). The questionnaire includes 5-items, and provides a total score from 1 to 25, with higher scores indicating better erectile function and lower scores indicating more severe erectile dysfunction.

Baseline

Group	Value	95% CI
SRT Plus Enzalutamide	7.36	± 9.16
SRT Plus Placebo	12.27	± 10.97

End of Treatment (180 days)

Group	Value	95% CI
SRT Plus Enzalutamide	4.8	± 7.55
SRT Plus Placebo	10.89	± 9.48

6 months Post-Treatment

Group	Value	95% CI
SRT Plus Enzalutamide	6.14	± 9.46
SRT Plus Placebo	16.25	± 10.5

Feasibility of Achieving Stated Accrual Secondary · 2 years

Anticipated accrual of participants versus actual reported enrollment. The goal is 48 in each arm.

Group	Value	95% CI
SRT Plus Enzalutamide	43
SRT Plus Placebo	43

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 2 years. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SRT Plus Enzalutamide

Serious: 0/43 (0%)

Deaths: 2/43

SRT Plus Placebo

Serious: 0/43 (0%)

Deaths: 0/43

Other adverse events (21 terms — click to expand)

Reaction	System	SRT Plus Enzalutamide	SRT Plus Placebo
fatigue	General disorders	—	—
urinary frequency/urgency	Renal and urinary disorders	—	—
nocturia	Nervous system disorders	—	—
diarrhea	Gastrointestinal disorders	—	—
sexuality alteration	General disorders	—	—
breast and nipple pain	General disorders	—	—
urinary incontinence	Renal and urinary disorders	—	—
erectile dysfunction	Nervous system disorders	—	—
hypertension	General disorders	—	—
hemmorrhoids	Gastrointestinal disorders	—	—
hot flashes	Endocrine disorders	—	—
nausea	Gastrointestinal disorders	—	—
pain (due to XRT)	General disorders	—	—
Proctitis	General disorders	—	—
Anorexia	Psychiatric disorders	—	—
hyperglycemia	Endocrine disorders	—	—
Urinary Retention	Renal and urinary disorders	—	—
lymphopenia	Blood and lymphatic system disorders	—	—
Back Pain	Musculoskeletal and connective tissue disorders	—	—
fall	General disorders	—	—
humerus fracture	General disorders	—	—

Data from ClinicalTrials.gov NCT02203695 adverse events section.

Sponsor's own description

The primary hypothesis of this study is that outcomes for patients with biochemically recurrent prostate cancer following radical prostatectomy will be improved by the addition of enzalutamide for 6-months compared to standard-of-care salvage radiation therapy to allow for further study in the definitive phase III setting. This study builds on the prior success of high-dose bicalutamide (for 24 months) when combined with salvage external radiation therapy (XRT), while using a newer more potent anti-androgen for a shorter duration of time (6 months) in an effort to minimize adverse effects.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Enzalutamide

Trials testing the same drug.

NCT07287150 — A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer · Phase 2 · recruiting
NCT07226986 — A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI i · Phase 1, PHASE2 · recruiting
NCT07277270 — A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tum · Phase 1 · recruiting
NCT07028853 — This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide W · Phase 3 · recruiting
NCT06922318 — The COSMYC Trial (COmbined Suppression of MYC) · Phase 2 · recruiting

Other recruiting trials for Adenocarcinoma of the Prostate

Currently open trials in the same condition.

NCT04909294 — Evaluation of the Efficacy and the Safety of a Stereotaxic Prostatic Radiotherapy Delivered With Linac MRI, in Patients · NA · active not recruiting
NCT02176902 — Low-Fat Diet and Fish Oil in Men on Active Surveillance for Prostate Cancer · NA · active not recruiting
NCT02023463 — Enzalutamide, Radiation Therapy and Hormone Therapy in Treating Patients With Intermediate or High-Risk Prostate Cancer · Phase 1 · active not recruiting
NCT02296229 — Stereotactic Body Radiation Therapy in Treating Patients With Localized High-Risk Prostate Cancer · NA · active not recruiting
NCT01655836 — High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer · Phase 1 · active not recruiting

Other Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins trials

Trials by the same sponsor.

NCT07424222 — Ruxolitinib for Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (RISE) · Phase 1 · not yet recruiting
NCT06210854 — Assessing Administration of pBI-11 Via Electroporation for the Treatment of Patients With HPV16/18+ · Phase 2 · not yet recruiting
NCT07360119 — Total Pancreatectomy With Islet Autotransplantation (TPIAT) for High-Risk Patients With Pancreatic Tumors · NA · not yet recruiting
NCT07140315 — DK222 Study at Hopkins · Phase 1 · recruiting
NCT07071155 — Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes/Myeloproliferative Ove · EARLY_PHASE1 · recruiting

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 NCT02203695 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last refreshed: 28 October 2025

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/NCT02203695.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing