Autopsy report · NCT00354432

Soy Protein/Effexor Hormone Therapy for Prostate Cancer

“Stopped by the DSMB for lack of effect per interim stopping rule.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 6 months before it started.
• Ran for about 3 years 6 months before it stopped.
• 120 participants enrolled.
• Results were posted on the registry 6 years 10 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Wake Forest University Health Sciences

Sponsor type

University, hospital or other

Conditions

Hot Flashes; Prostate Cancer

Interventions

oral soy protein/isoflavones powder; Venlafaxine; Placebo Powder; Placebo Pill

Participants

120

Sites

20

Countries

United States

Trials that died the same way

• Testing Pharmacological Therapies for Pregnant Smokers
  “was terminated due to meeting a priori stopping rule set by DSMB” (74% match in meaning)
• AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke
  “The DSMB halted the trial prematurely due to futility without any safety concerns.” (66% match in meaning)
• Randomized Trial of Primary Surgery Followed Selective Radiochemotherapy for Rectal Cancer With MRI Negative CRM
  “DSMB stopped this trial due to the difference of 3-year DFS's rate between two groups more than 5% at the interim analysis in July 2021.” (66% match in meaning)
• Helping HIV Infected Patients in South Africa Adhere to Drug Regimens
  “DSMB stopped trial for futility” (64% match in meaning)
• Estrogen Replacement to Reduce Risk of Neurologic Injury After Coronary Artery Bypass Graft Surgery
  “DSMB stopped the study based on conclusion of likely futility of treatment on the primary outcome.” (62% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.