Trial · NCT00106691
Prostate Cancer Prevention Study for Men With High Grade PIN (Prostatic Intraepithelial Neoplasia)
NCT00106691, Phase 3, Completed, GTx; results first posted 2023-06-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Prostate Cancer Prevention Study for Men With High Grade PIN (Prostatic Intraepithelial Neoplasia). Trials, record NCT00106691. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00106691
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prostate Cancer Prevention Study for Men With High Grade PIN (Prostatic Intraepithelial Neoplasia)
- NCT number
- NCT00106691
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,589 participants, actual
- Lead sponsor
- GTx
- Conditions
- Preneoplastic Conditions, Prostatic Intraepithelial Neoplasia
- Interventions
- Toremifene 20 mg, Placebo
- First posted
- 2005-03-30
- Last updated
- 2023-06-12
- Results first posted
- 2023-06-12
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of Toremifene in the Prevention of Prostate Cancer in Men With High Grade Prostatic Intraepithelial Neoplasia (PIN) | The outcome measurement time is up to 36 months | To measure the efficacy of toremifene citrate in men with high grade prostatic intraepithelial neoplasia (PIN). Prostate cancer-free survival distributions (Kaplan-Meier) |
| Primary | Occurrence of a Positive Cancer Biopsy | Up to 36 months | To measure the occurrence of a positive cancer biopsy |
| Secondary | The Effect of Toremifene on Lipid Levels | Up to 36 months | Measure lipid levels including total cholesterol, LDL, HDL and Triglycerides % change from baseline |
| Secondary | The Effect of Toremifene on Hormone Levels | Up to 36 months | % Change from baseline hormone levels, including total testosterone, free testosterone, dihydrotestosterone (DHT) and estradiol |
| Secondary | The Effect of Toremifene on Total PSA (Prostate Specific Antigen) Levels | Up to 36 months | To assess the effect of toremifene in the total PSA (prostate specific antigen) levels from baseline |
| Secondary | The Effect of Toremifene on the Mean Change at 36 Months in AUA (American Urological Association) Symptom Score | 36 months | To assess the effect of toremifene on the AUA (American Urological Association) symptom score mean change from baseline. Scores of 0-7=mild severity, 8-9, moderate, and 20-30, severe with possible responses of 0 (not at all) 1 (\<1/5), 2 (\<50% time), 3 (about 50% time), 4 (\> 50% time) \& 5 (Almost Always). There are 7 questions (1)Incomplete emptying (2)Frequency (3)Intermittency (4)Urgency (5)Weak-stream (6)Straining \& (7)Nocturia. Analysis is change from baseline at final evaluation (36 months) for quality of life due to urinary symptoms. The P Value is from a Wilcoxon signed-rank test. Scores can range from 0-35, highest representing worse symptoms |
| Secondary | Occurrence of High Grade PIN at the 12, 24, 36 Month Biopsies | Up to 36 months | To measure the occurrence of high grade PIN at the 12, 24, 36 Month intervals in the 360 days study. |
| Secondary | The Effect of Toremifene on % Free Serum PSA (Prostate Specific Antigen) Levels, Change From Baseline | 36 months | To assess the effect of toremifene in % free serum PSA (prostate specific antigen) levels, change from baseline |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy of Toremifene in the Prevention of Prostate Cancer in Men With High Grade Prostatic Intraepithelial Neoplasia (PIN) | The outcome measurement time is up to 36 months | MITT: Randomized subjects who were given study drug and did not return it unused and had a baseline and on-study prostate biopsy | % of participants cancer-free 36 months | NUMBER |
| SECONDARY | The Effect of Toremifene on Lipid Levels | Up to 36 months | All randomized subjects who take at least 1 dose of study drug | % of change | MEAN |
| SECONDARY | The Effect of Toremifene on Hormone Levels | Up to 36 months | Any randomized subject taking at least 1 dose of study drug | % of change | MEAN |
| SECONDARY | The Effect of Toremifene on Total PSA (Prostate Specific Antigen) Levels | Up to 36 months | Any randomized subject taking at least 1 dose of study drug | mcg/L | MEAN |
| SECONDARY | The Effect of Toremifene on the Mean Change at 36 Months in AUA (American Urological Association) Symptom Score | 36 months | Reference to J Urol.1992 Nov;148(5):1549-57; discussion 1564. AUA symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Assocciation. | scores on a scale | MEAN |
| PRIMARY | Occurrence of a Positive Cancer Biopsy | Up to 36 months | Modified, intend-to-treat (MITT) all randomized subj. who take at least 1 dose of study drug, and had baseline and on-study prostate biopsies, where the baseline biopsy did not have cancer. | Months | MEDIAN |
| SECONDARY | Occurrence of High Grade PIN at the 12, 24, 36 Month Biopsies | Up to 36 months | All randomized subjects that took 1 dose of study drug | Subjects | NUMBER |
| SECONDARY | The Effect of Toremifene on % Free Serum PSA (Prostate Specific Antigen) Levels, Change From Baseline | 36 months | Any randomized subject taking at least 1 dose of study drug | mcg/L | MEAN |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy of Toremifene in the Prevention of Prostate Cancer in Men With High Grade Prostatic Intraepithelial Neoplasia (PIN) | Placebo | 54.9 | 95% Confidence Interval 36.0 | % of participants cancer-free 36 months | |
| Efficacy of Toremifene in the Prevention of Prostate Cancer in Men With High Grade Prostatic Intraepithelial Neoplasia (PIN) | Toremifene 20mg | 59.5 | 95% Confidence Interval 36.0 | % of participants cancer-free 36 months | |
| The Effect of Toremifene on Lipid Levels | Placebo | Cholesterol | -3.678 | Standard Deviation 18.2317 | % of change |
| The Effect of Toremifene on Lipid Levels | Toremifene 20mg | Cholesterol | -6.675 | Standard Deviation 116.9705 | % of change |
| The Effect of Toremifene on Lipid Levels | Placebo | LDL | -7.447 | Standard Deviation 64.8765 | % of change |
| The Effect of Toremifene on Lipid Levels | Toremifene 20mg | LDL | -7.824 | Standard Deviation 28.8209 | % of change |
| The Effect of Toremifene on Lipid Levels | Placebo | HDL | 3.69 | Standard Deviation 19.133 | % of change |
| The Effect of Toremifene on Lipid Levels | Toremifene 20mg | HDL | 0.29 | Standard Deviation 16.650 | % of change |
| The Effect of Toremifene on Lipid Levels | Placebo | Triglycerides | 16.298 | Standard Deviation 58.003 | % of change |
| The Effect of Toremifene on Lipid Levels | Toremifene 20mg | Triglycerides | 0.319 | Standard Deviation 47.9793 | % of change |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 802 | |
| Overall Study | STARTED | Toremifene 20mg | 787 | |
| Overall Study | COMPLETED | Placebo | 598 | |
| Overall Study | COMPLETED | Toremifene 20mg | 588 | |
| Overall Study | NOT COMPLETED | Placebo | 204 | |
| Overall Study | NOT COMPLETED | Toremifene 20mg | 199 |
Source ClinicalTrials.gov
Adverse events334
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 | Hypertension | Vascular disorders | Placebo | 70 | 802 | 70 |
| other | Hypertension | Vascular disorders | Toremifene 20mg | 52 | 787 | 52 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 50 | 802 | 61 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Toremifene 20mg | 46 | 787 | 50 |
| other | Urinary tract infection | Infections and infestations | Placebo | 54 | 802 | 65 |
| other | Urinary tract infection | Infections and infestations | Toremifene 20mg | 41 | 787 | 45 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 46 | 802 | 57 |
| other | Upper respiratory tract infection | Infections and infestations | Toremifene 20mg | 45 | 787 | 53 |
| other | Prostatitis | Reproductive system and breast disorders | Placebo | 49 | 802 | 62 |
| other | Prostatitis | Reproductive system and breast disorders | Toremifene 20mg | 39 | 787 | 43 |
1 to 10 of 334Source ClinicalTrials.gov
See all 334 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Toremifene 20mg | ||
| Total, other adverse events | Placebo | 666 | 802 |
| Total, other adverse events | Toremifene 20mg | 631 | 787 |
| Total, serious adverse events | Placebo | 137 | 802 |
| Total, serious adverse events | Toremifene 20mg | 117 | 787 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23295793 | DERIVED |
Source 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 |
|---|
| Toremifene 20mg vs Placebo: serious 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.
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/NCT00106691
GET https://conductscience.org/api/trials/v1/NCT00106691/results?page=2