Trial · NCT03725761

Sacituzumab Govitecan in Patients With Metastatic Castration-Resistant Prostate Cancer Progressing on Second Generation AR-Directed Therapy

NCT03725761, Phase 2, Active not recruiting, University of Wisconsin, Madison; results first posted 2025-04-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Sacituzumab Govitecan in Patients With Metastatic Castration-Resistant Prostate Cancer Progressing on Second Generation AR-Directed Therapy. Trials, record NCT03725761. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03725761

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Sacituzumab Govitecan in Patients With Metastatic Castration-Resistant Prostate Cancer Progressing on Second Generation AR-Directed Therapy
NCT number: NCT03725761
Status: Active not recruiting
Phases: Phase 2
Enrollment: 31 participants, actual
Lead sponsor: University of Wisconsin, Madison
Conditions: Prostate Cancer
Interventions: Sacituzumab Govitecan
First posted: 2018-10-31
Last updated: 2026-06-04
Results first posted: 2025-04-24

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	PSA Response Rate	up to 9 weeks	Subjects who achieve ≥50% PSA decline at or before 9 weeks of therapy with Sacituzumab Govitecan (IMMU-132) are considered to have responded. PSA responses will be analyzed by descriptive statistics and summarized in tabular format (frequency tables). The overall PSA response rate will be reported along with the corresponding 95% confidence interval which will be constructed using the Wilson score method.
Primary	6-Month Progression Free Survival Rate	6 months	Proportion of participants remaining alive and progression free (using Prostate Cancer Working Group 2 (PCWG2) criteria) 6 months from time of starting treatment as estimated by the Kaplan-Meier method.
Secondary	Median Progression Free Survival Rate	Up to 2 years from start of treatment	The probability distribution of Progression Free Survival (PFS) will be estimated using the Kaplan-Meier method. The median will be estimated from this distribution. Subjects who have not died or progressed (using PCWG2 criteria) will be censored at the date of last assessment.
Secondary	Radiologic Response Rate	up to 2 years from start of treatment	The number of participants with progressive disease, stable disease, partial response and complete response will be summarized in tabular format. The overall response rate will be reported along with the corresponding 95% confidence interval which will be constructed using the Wilson score method.
Secondary	Median Overall Survival	Up to 2 years from start of treatment	Overall Survival (OS) is the duration from start of treatment until death from any cause. The probability distribution of OS will be estimated using the Kaplan-Meier method. The median will be estimated from this distribution. Subjects who have not died will be censored at the date of last contact.
Secondary	Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.)	Up to 9 weeks from start of treatment	Toxicities will be summarized by type and severity in tabular format. Toxicity rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, etc.) will be calculated and reported along the corresponding 95% confidence intervals. The 95% confidence intervals will be constructed using the Wilson score method.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	PSA Response Rate	up to 9 weeks	percent	NUMBER
PRIMARY	6-Month Progression Free Survival Rate	6 months	percent	NUMBER
SECONDARY	Median Progression Free Survival Rate	Up to 2 years from start of treatment
SECONDARY	Radiologic Response Rate	up to 2 years from start of treatment
SECONDARY	Median Overall Survival	Up to 2 years from start of treatment
SECONDARY	Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.)	Up to 9 weeks from start of treatment	number of adverse events	COUNT_OF_UNITS

Source ClinicalTrials.gov

Results by group158

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
PSA Response Rate	Sacituzumab Govitecan Treatment		6	95% Confidence Interval 2 to 21	percent
6-Month Progression Free Survival Rate	Sacituzumab Govitecan Treatment		52		percent
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.)	Grade 2	Alopecia	10		number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.)	Grade 3	Alopecia	0		number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.)	Grade 4	Alopecia	0		number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.)	Greater Than or Equal to 2	Alopecia	10		number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.)	Greater Than or Equal to 3	Alopecia	0		number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.)	Greater Than or Equal to 4	Alopecia	0		number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.)	Grade 2	Anemia	8		number of adverse events
Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.)	Grade 3	Anemia	4		number of adverse events

1 to 10 of 158Source ClinicalTrials.gov

See all 158 results by group

Participant flow7

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Sacituzumab Govitecan Treatment	31
Overall Study	Received Treatment	Sacituzumab Govitecan Treatment	31
Overall Study	Off Study Treatment Early	Sacituzumab Govitecan Treatment	11
Overall Study	Completed Treatment	Sacituzumab Govitecan Treatment	19
Overall Study	Currently on Treatment	Sacituzumab Govitecan Treatment	1
Overall Study	COMPLETED	Sacituzumab Govitecan Treatment	30
Overall Study	NOT COMPLETED	Sacituzumab Govitecan Treatment	1

Source ClinicalTrials.gov

Adverse events134

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anemia	Blood and lymphatic system disorders	Sacituzumab Govitecan Treatment	17	31	31
other	Febrile Neutropenia	Blood and lymphatic system disorders	Sacituzumab Govitecan Treatment	1	31	1
other	Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	Sacituzumab Govitecan Treatment	1	31	1
other	Heart Failure	Cardiac disorders	Sacituzumab Govitecan Treatment	1	31	1
other	Sinus Tachycardia	Cardiac disorders	Sacituzumab Govitecan Treatment	1	31	1
other	Adrenal Insufficiency	Endocrine disorders	Sacituzumab Govitecan Treatment	1	31	1
other	Chills	General disorders	Sacituzumab Govitecan Treatment	3	31	3
other	Debility	General disorders	Sacituzumab Govitecan Treatment	1	31	1
other	Edema Limbs	General disorders	Sacituzumab Govitecan Treatment	2	31	2
other	Fatigue	General disorders	Sacituzumab Govitecan Treatment	13	31	17

1 to 10 of 134Source ClinicalTrials.gov

See all 134 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sacituzumab Govitecan Treatment	30	31
Total, other adverse events	Sacituzumab Govitecan Treatment	31	31
Total, serious adverse events	Sacituzumab Govitecan Treatment	12	31

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA014520	UW Comprehensive Cancer Center Support	CAPITINI, CHRISTIAN	UNIVERSITY OF WISCONSIN-MADISON	NATIONAL CANCER INSTITUTE	1985 to 2025

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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