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Prostate CancerPhase 2/3NCT00765479

Soy Protein in Preventing Recurrent Cancer in Patients Who Have Undergone Surgery for Stage II Prostate Cancer

A Phase 2/3 study testing soy protein isolate in people with Prostate Cancer, run by University of Illinois Chicago at 1 site in United States.

Completed

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

Official record
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Trial summary

RATIONALE: Soy protein may help prevent prostate cancer recurrence in patients who have undergone surgery for prostate cancer. PURPOSE: This randomized phase II/III trial is studying how well soy protein works and compares it to a placebo in preventing recurrent cancer in patients who have undergone surgery for stage… Read more about this study

Who is it for?
Ages 40 to 75 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
soy protein isolate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
284 participants
Where
1 siteUnited States
Study dates
Dec 2006to Jul 2013
Phase
Phase 2/3
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 40 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of prostate cancer
  • Clinically localized (T1c or T2) disease
  • At high risk for recurrence, as defined by ≥ 1 of the following:
  • Preoperative PSA > 20.0 ng/mL
  • Seminal vesicle invasion
  • Extracapsular extension (excluding the bladder neck)
  • Positive surgical margins (excluding apical margins)
  • Micrometastases in any removed pelvic lymph nodes
  • Final Gleason score of ≥ 8
  • Must have undergone radical prostatectomy for prostate cancer within the past 4 months
  • Must have an undetectable PSA (< 0.07 ng/mL) at baseline, as measured by Tosoh PSA assay
  • No clinical evidence of locally recurrent or metastatic disease

PATIENT CHARACTERISTICS:

  • No significant intake of soy (i.e., more than once a week) at baseline including, but not limited to, any of the following:
  • Vegetarians who regularly consume soy products (e.g., tofu)
  • Individuals with customary Asian dietary habits, including regular intake of soy products
  • Individuals who use soy-based milk replacements
  • No anemia, iron deficiency problems, or subclinical iron deficiency at baseline
  • No diabetes
  • No thyroid disease
  • No requirement for a sodium-free diet
  • No substantive tendency to be constipated (i.e., ≥ grade 2 constipation experienced regularly)
  • No medical problem that would preclude the consumption of the soy containing beverage powder, including allergies against soy (or milk protein)
  • No concurrent major disease, including major mental disease or major substance abuse problems
  • No significant side effects from medication

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No concurrent radiotherapy or hormonal therapy
  • No other concurrent adjuvant therapy for prostate cancer

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612-7243

Other trials in United States

About this study

Official title: Randomized Placebo-Controlled Adjuvant Study of Prevention of Prostate Cancer Recurrence After Radical Prostatectomy by Soy Protein Isolate

RATIONALE: Soy protein may help prevent prostate cancer recurrence in patients who have undergone surgery for prostate cancer.

PURPOSE: This randomized phase II/III trial is studying how well soy protein works and compares it to a placebo in preventing recurrent cancer in patients who have undergone surgery for stage II prostate cancer.

Read the detailed description

OBJECTIVES:

  • Determine whether soy protein isolate reduces the PSA failure rate and time to PSA failure within 2 years following radical prostatectomy in patients who are at high risk for prostate cancer recurrence.
  • Determine the effects of soy protein isolate on intermediate biomarkers of steroid hormone axis (testosterone, estradiol, and SHBG) and thyroid activity (T3 and T4).
  • Determine the effects of soy protein isolate on intermediate biomarkers of apoptosis (soluble Fas and Fas-ligand), angiogenesis (VEGF and bFGF), antioxidant activity (8-isoprostanes), and IGF axis (IGF-1 and IGFBP-3).
  • Compare patients who are equol producers to those who are non-producers.

OUTLINE: This is a multicenter study. Patients are stratified according to hospital/clinic site (NYU vs UIC or Jesse Brown VA Medical Center vs other sites), number of high-risk characteristics (1 vs > 1), and race (African American vs non-African American [i.e., non-Hispanic White, Hispanic, Asian, and other]). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive an oral soy protein isolate beverage once daily.
  • Arm II: Patients receive an oral casein placebo beverage once daily. Treatment in both arms continues for up to 2 years in the absence of disease progression or unacceptable toxicity.

Blood samples are collected periodically for biomarker laboratory studies. Samples are analyzed to measure PSA levels by Tosoh PSA assay; cholesterol levels; isoflavone and equol concentrations by HPLC and ESA; and indicators of steroid hormone axis (testosterone, estradiol, and SHBG), indicators of thyroid activity (T3 and T4), indicators of apoptosis (soluble Fas and Fas-ligand), indicators of angiogenesis (VEGF and bFGF), indicators of oxidative stress (8-isoprostanes), and indicators of IGF axis (IGF-1 and IGFBP-3) by ELISA.

Conditions
Prostate Cancer
Being tested
soy protein isolate, placebo
Keywords
stage IIB prostate cancer, stage IIA prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • soy protein isolateDietary supplement

    Given orally

  • placeboOther

    Given orally

Study groups in NCT00765479
Study groupRoleWhat they receive
Arm IExperimentalPatients receive an oral soy protein isolate beverage once daily.
Receives: Dietary Supplement: soy protein isolate
Arm IIPlacebo comparatorPatients receive an oral casein placebo beverage once daily.
Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Two-year PSA failure rate (as surrogate for recurrence)

  2. Time to PSA failure

Secondary outcomes (9)

  1. Isoflavone uptake or compliance as measured by serum isoflavone concentration

  2. Serum total cholesterol levels

  3. Steroid hormone axis as measured by serum testosterone, estradiol, and SHBG levels

  4. Thyroid activity as measured by serum T3 and T4 levels

  5. Apoptotic activity as measured by serum soluble Fas and Fas-ligand levels

  6. Angiogenesis as measured by serum VEGF and bFGF levels

  7. Oxidative stress as measured by serum 8-isoprostane levels

  8. IGF axis as measured by serum IGF-1 and IGFBP-3 levels

  9. Equol production as measured by serum equol concentration

Timeline

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

  1. First posted3 Oct 2008 (estimated)
  2. Study startDec 2006
  3. Primary completionSep 2011
  4. Study completionJul 2013

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Masking
Double blind
Enrolment
284 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00765479
Sponsor's protocol ID
CDR0000615902
Other IDs
UIC-2006-0706
Status last verified
Aug 2009
First submitted
2 Oct 2008
Last updated
20 Sep 2013
Results posted
No

Publications

  • Bosland MC, Enk E, Schmoll J, Schlicht MJ, Randolph C, Deaton RJ, Xie H, Zeleniuch-Jacquotte A, Kato I. Soy protein supplementation in men following radical prostatectomy: a 2-year randomized, placebo-controlled clinical trial. Am J Clin Nutr. 2021 Apr 6;113(4):821-831. doi: 10.1093/ajcn/nqaa390.

    PubMed 33564828

  • Bosland MC, Huang J, Schlicht MJ, Enk E, Xie H, Kato I. Impact of 18-Month Soy Protein Supplementation on Steroid Hormones and Serum Biomarkers of Angiogenesis, Apoptosis, and the Growth Hormone/IGF-1 Axis: Results of a Randomized, Placebo-Controlled Trial in Males Following Prostatectomy. Nutr Cancer. 2022;74(1):110-121. doi: 10.1080/01635581.2020.1870706. Epub 2021 Jan 12.

    PubMed 33432829

  • Bosland MC, Kato I, Zeleniuch-Jacquotte A, Schmoll J, Enk Rueter E, Melamed J, Kong MX, Macias V, Kajdacsy-Balla A, Lumey LH, Xie H, Gao W, Walden P, Lepor H, Taneja SS, Randolph C, Schlicht MJ, Meserve-Watanabe H, Deaton RJ, Davies JA. Effect of soy protein isolate supplementation on biochemical recurrence of prostate cancer after radical prostatectomy: a randomized trial. JAMA. 2013 Jul 10;310(2):170-8. doi: 10.1001/jama.2013.7842.

    PubMed 23839751

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing soy protein isolate in people with Prostate Cancer, run by University of Illinois Chicago at 1 site in United States.

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 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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.

What does the primary outcome measure?

Two-year PSA failure rate (as surrogate for recurrence). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00765479, which also lists 3 linked publications.

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 20 Sep 2013.

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