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AzTrials

Prostate CancerPhase 2NCT00068731

Lycopene in Treating Patients With Metastatic Prostate Cancer

A Phase 2 study testing lycopene in people with Prostate Cancer, run by Alliance for Clinical Trials in Oncology at 18 sites 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: Lycopene, a substance found in tomatoes, may lower prostate-specific antigen (PSA) levels and slow or prevent the development of prostate cancer. PURPOSE: Phase II trial to study the effectiveness of lycopene in treating patients who have asymptomatic metastatic prostate cancer and a rising PSA level. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
lycopene
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
18 sitesUnited States
Study dates
Jan 2004to Oct 2009
Phase
Phase 2
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 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of androgen-independent prostate cancer
  • Asymptomatic metastatic disease
  • Unlikely to become symptomatic within the next 4 months
  • No bone pain, shortness of breath, fatigue, or urinary symptoms directly attributable to prostate cancer
  • Radiologic, physically palpable, and/or biochemical evidence of tumor progression after prior orchiectomy OR during treatment with a luteinizing hormone-releasing hormone (LHRH) agonist OR after initiation of another hormonal agent
  • Sustained prostate-specific antigen (PSA) elevation, defined by the following:
  • PSA greater than 5 ng/mL
  • At least 2 consecutive increases in PSA at least 1 week apart
  • Sustained increase in PSA at least 4 weeks after discontinuation of prior flutamide (or other antiandrogen therapy) or megestrol AND at least 6 weeks after discontinuation of prior bicalutamide
  • No known CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Not specified

Hepatic

  • Bilirubin no greater than 1.5 mg/dL* NOTE: *Includes patients with liver involvement secondary to tumor

Renal

  • See Disease Characteristics
  • Creatinine no greater than 2 times upper limit of normal

Pulmonary

  • See Disease Characteristics

Other

  • No other malignancy within the past 5 years except basal cell skin cancer
  • No medical or psychiatric condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior immunotherapy

Chemotherapy

  • More than 4 weeks since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • More than 4 weeks since prior hormonal therapy (other than an LHRH agonist)
  • No concurrent corticosteroids
  • No concurrent progestational agents
  • No concurrent new hormonal therapy

Radiotherapy

  • No concurrent radiotherapy, including radiotherapy for new bone disease

Surgery

  • See Disease Characteristics

Other

  • More than 4 weeks since other prior anticancer therapy
  • No other concurrent investigational anticancer agents
  • No other concurrent alternative medicine therapies (e.g., saw palmetto or PC-SPES)

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342-1701

  • Medcenter One Health System

    Bismarck, North Dakota, 58501-5505

  • CCOP - Cedar Rapids Oncology Project

    Cedar Rapids, Iowa, 52403-1206

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309-1016

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615-7828

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Coborn Cancer Center

    Saint Cloud, Minnesota, 56303

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • CCOP - Mayo Clinic Scottsdale Oncology Program

    Scottsdale, Arizona, 85259-5404

  • Siouxland Hematology-Oncology

    Sioux City, Iowa, 51101-1733

  • CCOP - Sioux Community Cancer Consortium

    Sioux Falls, South Dakota, 57104

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

Other trials in United States

About this study

Official title: A Phase II Trial Of Lycopene For Patients With Asymptomatic Androgen-Independent Metastatic Prostate Cancer With PSA Elevation

RATIONALE: Lycopene, a substance found in tomatoes, may lower prostate-specific antigen (PSA) levels and slow or prevent the development of prostate cancer.

PURPOSE: Phase II trial to study the effectiveness of lycopene in treating patients who have asymptomatic metastatic prostate cancer and a rising PSA level.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the percentage of patients with asymptomatic androgen-independent metastatic prostate cancer and an elevated prostate-specific antigen (PSA) level who sustain a decline in PSA after 4 months of treatment with lycopene.

Secondary

  • Determine the response duration of PSA decline in patients treated with this therapy.
  • Determine the time to the first consistent PSA increase in patients treated with this therapy.
  • Determine whether a decline in PSA coincides with evidence of disease regression on physical examination or radiographic assessment in patients treated with this therapy.
  • Determine the adverse event profile of this therapy in these patients.
  • Determine the factors that motivate prostate cancer patients to enroll in a nutritional-based therapy study.

OUTLINE: This is a multicenter study.

Patients receive oral lycopene twice daily on days 1-28. Courses repeat every 28 days for at least 4 months in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.

Conditions
Prostate Cancer
Being tested
lycopene
Keywords
stage IV prostate cancer, recurrent 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.

  • lycopeneDietary supplement

Study groups in NCT00068731
Study groupRoleWhat they receive
lycopeneExperimentalPatients receive oral lycopene twice daily on days 1-28. Courses repeat every 28 days for at least 4 months in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
Receives: Dietary Supplement: lycopene

What is being measured

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

  1. percentage of patients with asymptomatic androgen-independent metastatic prostate cancer and an elevated prostate-specific antigen (PSA) level who sustain a decline in PSA after 4 months of treatment with lycopene

    Measured: Up to 4 months

Secondary outcomes (3)

  1. response duration

    Measured: Up to 5 years

  2. time to the first consistent PSA increase

    Measured: Up to 5 years

  3. disease regression

    Measured: Up to 5 years

Timeline

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

  1. First posted11 Sep 2003 (estimated)
  2. Study startJan 2004
  3. Primary completionFeb 2007
  4. Study completionOct 2009

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00068731
Sponsor's protocol ID
NCCTG-N0351
Other IDs
NCI-2012-02555, CDR0000327843
Status last verified
Jul 2016
First submitted
10 Sep 2003
Last updated
13 Jul 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Jatoi A, Burch P, Hillman D, Vanyo JM, Dakhil S, Nikcevich D, Rowland K, Morton R, Flynn PJ, Young C, Tan W; North Central Cancer Treatment Group. A tomato-based, lycopene-containing intervention for androgen-independent prostate cancer: results of a Phase II study from the North Central Cancer Treatment Group. Urology. 2007 Feb;69(2):289-94. doi: 10.1016/j.urology.2006.10.019.

    PubMed 17320666

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing lycopene in people with Prostate Cancer, run by Alliance for Clinical Trials in Oncology at 18 sites 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 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

percentage of patients with asymptomatic androgen-independent metastatic prostate cancer and an elevated prostate-specific antigen (PSA) level who sustain a decline in PSA after 4 months of treatment with lycopene (time frame: Up to 4 months). 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 NCT00068731, 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 13 Jul 2016.

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