AzTrials
AzTrials

Precancerous/Nonmalignant ConditionPhase 3NCT00064194

Vitamin E, Selenium, and Soy Protein in Preventing Cancer in Patients With High-Grade Prostate Neoplasia

A Phase 3 study testing selenium, soy protein isolate and vitamin E in people with Precancerous/Nonmalignant Condition and Prostate Cancer, run by NCIC Clinical Trials Group at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development or recurrence of cancer. Vitamin E, selenium, and soy protein may be effective in preventing the development of prostate cancer. Read more about this study

Who is it for?
Ages Up to 120 years, men only
What is being tested?
selenium, soy protein isolate and vitamin E
How many people
310 participants
Where
3 sitesCanada
Study dates
28 Nov 2001to 30 Apr 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 120 years
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed high-grade prostatic intraepithelial neoplasia (HGPIN)
  • No evidence of invasive prostate cancer by at least 2 biopsies within the past 18 months
  • At least 1 biopsy must show evidence of HGPIN within the past 6 months
  • No prior invasive prostate cancer

PATIENT CHARACTERISTICS:

Age

  • Not specified

Performance status

  • Not specified

Life expectancy

  • More than 5 years

Hematopoietic

  • Platelet count at least 75,000/mm^3
  • No coagulopathies

Hepatic

  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • PT (INR) no greater than 1.5 times ULN
  • PTT no greater than 1.5 times ULN
  • No hepatic insufficiencies

Renal

  • Creatinine no greater than 2 times ULN
  • No renal insufficiencies

Other

  • No prior nonmelanoma skin cancer (e.g., squamous cell or basal cell carcinoma)
  • No other malignancy within the past 5 years except superficial bladder cancer
  • No known bowel malabsorption
  • No dietary behavior (e.g., morbid obesity or eating disorders) that would limit adherence to study therapy
  • No major illness, including psychiatric illness, that would preclude study compliance and follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • More than 3 months since prior androgen therapy
  • More than 3 months since prior hormonal therapy for benign prostatic hyperplasia (e.g., finasteride)
  • No concurrent finasteride
  • No concurrent androgen therapy

Radiotherapy

  • More than 2 years since prior radiotherapy to the pelvic region

Surgery

  • Not specified

Other

  • More than 2 weeks since prior supplemental vitamin E or selenium
  • No other concurrent vitamin E (greater than 100 IU/day), selenium, or soy protein isolate (more than 2 servings/week)
  • No other concurrent treatment for high-grade prostatic intraepithelial neoplasia

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Double-Blind, Placebo-Controlled, Randomized Study Of Combination Vitamin E, Selenium And Soy Protein Product In Subjects With High Grade Prostatic Intraepithelial Neoplasia

RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development or recurrence of cancer. Vitamin E, selenium, and soy protein may be effective in preventing the development of prostate cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of combining vitamin E, selenium, and soy protein in preventing prostate cancer in patients who have high-grade prostate neoplasia.

Read the detailed description

OBJECTIVES:

  • Determine whether nutritional supplementation with soy protein isolate, vitamin E, and selenium can delay the time to development of invasive prostate cancer (disease-free survival) in patients with high-grade prostatic intraepithelial neoplasia.
  • Determine the effect of this supplementation on intermediate endpoints that may reflect a lessened risk of invasive prostate cancer (e.g., serum PSA levels, hormone levels, lycopene, malondialdehyde, vitamin E, and reduced thiol groups) in these patients.
  • Determine the safety of this supplementation in these patients.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral vitamin E, oral selenium, and oral soy protein isolate twice daily.
  • Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for 3 years in the absence of invasive prostate cancer (demonstrated on biopsy) or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 306 patients (153 per treatment arm) will be accrued for this study within 6 years.

Being tested
selenium, soy protein isolate, vitamin E
Keywords
prostate cancer, high grade prostatic intraepithelial neoplasia
Medical subject headings
Precancerous Conditions, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • seleniumDietary supplement

  • soy protein isolateDietary supplement

  • vitamin EDietary supplement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2003 (estimated)
  2. Study start28 Nov 2001
  3. Primary completion30 Apr 2008
  4. Study completion30 Apr 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
310 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00064194
Sponsor's protocol ID
PRP1
Other IDs
CAN-NCIC-PRP1, CDR0000310096
Status last verified
Apr 2020
First submitted
8 Jul 2003
Last updated
3 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fleshner NE, Kapusta L, Donnelly B, Tanguay S, Chin J, Hersey K, Farley A, Jansz K, Siemens DR, Trpkov K, Lacombe L, Gleave M, Tu D, Parulekar WR. Progression from high-grade prostatic intraepithelial neoplasia to cancer: a randomized trial of combination vitamin-E, soy, and selenium. J Clin Oncol. 2011 Jun 10;29(17):2386-90. doi: 10.1200/JCO.2010.32.0994. Epub 2011 May 2.

    PubMed 21537051

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing selenium, soy protein isolate and vitamin E in people with Precancerous/Nonmalignant Condition and Prostate Cancer, run by NCIC Clinical Trials Group at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00064194, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in