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Trial · NCT00586898

Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle

NCT00586898, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2016-03-25

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle. Trials, record NCT00586898. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00586898

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Trial

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

Title
Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle
NCT number
NCT00586898
Status
Completed
Phases
Phase 2
Enrollment
36 participants, actual
Lead sponsor
Memorial Sloan Kettering Cancer Center
Conditions
Prostate, Cancer, Hormonal Cycling
Interventions
GnRH, Ketoconazole, Bicalutamide, Testosterone transdermal gel, Estrogen transdermal patch
First posted
2008-01-07
Last updated
2016-03-25
Results first posted
2016-03-25

Source ClinicalTrials.gov

Registered outcomes1

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

ListOutcomeTime frameDescription
PrimaryResponse6 months
Complete Response: Normalization of the PSA (\< or = to 4.0 for patients with castrate metastatic disease, or \< 0.5 for patients with a rising PSA) that is maintained on 3 successive evaluations a minimum of 2 weeks apart. Partial Response: Decrease in PSA value by \> or = to 50% from baseline value (without normalization) for 3 successive evaluations a minimum of 2 weeks apart. Stabilization: Patients who do not meet the criteria for PR or PROG for at least 90 days will be considered stable.

Outcomes1

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYResponse6 monthsparticipantsNUMBER

Results by group3

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

OutcomeGroupCategoryValueSpreadUnits
ResponseAll ParticipantsComplete Response (CR)22participants
ResponseAll ParticipantsPartial Response (PR)4participants
ResponseAll ParticipantsStable Disease (SD)3participants

Participant flow3

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

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDAll Participants36
Overall StudyCOMPLETEDAll Participants29
Overall StudyNOT COMPLETEDAll Participants7

Adverse events8

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

TypeEventOrgan systemGroupAffectedAt riskEvents
otherDyspneaRespiratory, thoracic and mediastinal disordersAll Participants6366
otherHot FlashesGeneral disordersAll Participants7367
otherHyperglycemiaMetabolism and nutrition disordersAll Participants8368
otherHyperkalemiaMetabolism and nutrition disordersAll Participants5365
otherHypoglycemiaMetabolism and nutrition disordersAll Participants2362
otherSGPT (ALT)Metabolism and nutrition disordersAll Participants3363
seriousPneumonitisRespiratory, thoracic and mediastinal disordersAll Participants1361
seriousCardiovascular, otherCardiac disordersAll Participants1361

Adverse event totals3

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityAll Participants
Total, other adverse eventsAll Participants2036
Total, serious adverse eventsAll Participants236

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 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.

GET https://conductscience.org/api/trials/v1/NCT00586898

GET https://conductscience.org/api/trials/v1/NCT00586898/registered