Trial · NCT00004635

Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer

NCT00004635, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2012-09-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer. Trials, record NCT00004635. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00004635

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Trial

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

Title: Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer
NCT number: NCT00004635
Status: Completed
Phases: Phase 3
Enrollment: 159 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Prostate Cancer
Interventions: Thalidomide, leuprolide acetate, goserelin, Placebo
First posted: 2000-02-21
Last updated: 2018-05-22
Results first posted: 2012-09-12
Limitations and caveats: A total of 159 participants were accrued beginning in March 2000 until January 2005. Accrual rates were less than anticipated and the study was closed to further entry by the Independent Data Safety and Monitoring Board for the NCI CCR.

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Time to Progression	36 months	Time to progression is defined as follows: if the PSA returns to baseline (defined as the PSA value prior to starting leuprolide or goserelin) or increases to the absolute value of 5 ng/ml.
Secondary	The Number of Participants With Adverse Events	Date treatment consent signed to date off study, approximately 60 months	Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time to Progression	36 months	Per protocol. First intervention phase-73 participants (thalidomide) were analyzed and 0 was excluded; 74 participants were analyzed (placebo) and 1 was excluded for discrepancy in data entry. Crossover phase-50 participants were analyzed (thalidomide)and 1 was excluded for discrepancy in data entry, 38 participants for placebo and 0 excluded.	months	MEDIAN
SECONDARY	The Number of Participants With Adverse Events	Date treatment consent signed to date off study, approximately 60 months		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Spread	Units
Time to Progression	Thalidomide	15	95% Confidence Interval 12.0 to 22.1	months
Time to Progression	Placebo	9.6	95% Confidence Interval 8.5 to 12.9	months
The Number of Participants With Adverse Events	Thalidomide	117		Participants
The Number of Participants With Adverse Events	Placebo	98		Participants

Source ClinicalTrials.gov

Participant flow14

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

Period	Milestone	Group	Participants
Period One	STARTED	Thalidomide Followed by Placebo	79
Period One	STARTED	Placebo Followed by Thalidomide	80
Period One	Received Treatment	Thalidomide Followed by Placebo	73
Period One	Received Treatment	Placebo Followed by Thalidomide	75
Period One	COMPLETED	Thalidomide Followed by Placebo	73
Period One	COMPLETED	Placebo Followed by Thalidomide	74
Period One	NOT COMPLETED	Thalidomide Followed by Placebo	6
Period One	NOT COMPLETED	Placebo Followed by Thalidomide	6
Period Two	STARTED	Thalidomide Followed by Placebo	44
Period Two	STARTED	Placebo Followed by Thalidomide	59

1 to 10 of 14Source ClinicalTrials.gov

See all 14 participant flow

Adverse events1,076

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	Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	Immune system disorders	Thalidomide	2	138	2
other	Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	Immune system disorders	Placebo	1	124	1
other	Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	Immune system disorders	Goserelin (Zoladex)	0	159	0
other	Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	Immune system disorders	Leuprolide	0	159	0
other	Abdominal pain or cramping	Reproductive system and breast disorders	Thalidomide	2	138	2
other	Abdominal pain or cramping	Reproductive system and breast disorders	Placebo	3	124	3
other	Abdominal pain or cramping	Reproductive system and breast disorders	Goserelin (Zoladex)	0	159	0
other	Abdominal pain or cramping	Reproductive system and breast disorders	Leuprolide	0	159	0
other	Alkaline phosphatase	Investigations	Thalidomide	2	138	3
other	Alkaline phosphatase	Investigations	Placebo	1	124	1

1 to 10 of 1,076Source ClinicalTrials.gov

See all 1,076 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Thalidomide	0	138
Total, all-cause mortality	Placebo	0	124
Total, all-cause mortality	Goserelin (Zoladex)	0	159
Total, all-cause mortality	Leuprolide	0	159
Total, other adverse events	Thalidomide	67	138
Total, other adverse events	Placebo	63	124
Total, other adverse events	Goserelin (Zoladex)	10	159
Total, other adverse events	Leuprolide	66	159
Total, serious adverse events	Thalidomide	117	138
Total, serious adverse events	Placebo	98	124

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
5652850	BACKGROUND	PubMed
6093713	BACKGROUND	PubMed
9714301	BACKGROUND	PubMed
19167733	RESULT	PubMed
31899823	DERIVED	PubMed

Grants0

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.

None in this release.

Trial comparisons1

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

Comparison
Thalidomide vs Placebo: The Number of Participants With Adverse Events

Source Trial comparisons

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.

GET https://conductscience.org/api/trials/v1/NCT00004635

GET https://conductscience.org/api/trials/v1/NCT00004635/events?page=2

API reference For AI assistants