Lycopene in Treating Patients With Metastatic Prostate Cancer
This study has been completed.
Sponsor:
North Central Cancer Treatment Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00068731
First received: September 10, 2003
Last updated: November 13, 2009
Last verified: October 2004
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Dietary Supplement: lycopene |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial Of Lycopene For Patients With Asymptomatic Androgen-Independent Metastatic Prostate Cancer With PSA Elevation |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | January 2004 |
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.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 1 year.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068731
Locations
| United States, Arizona | |
| CCOP - Mayo Clinic Scottsdale Oncology Program | |
| Scottsdale, Arizona, United States, 85259-5404 | |
| United States, Florida | |
| Mayo Clinic - Jacksonville | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Georgia | |
| CCOP - Atlanta Regional | |
| Atlanta, Georgia, United States, 30342-1701 | |
| United States, Illinois | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61615-7828 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| United States, Iowa | |
| CCOP - Cedar Rapids Oncology Project | |
| Cedar Rapids, Iowa, United States, 52403-1206 | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309-1016 | |
| Siouxland Hematology-Oncology | |
| Sioux City, Iowa, United States, 51101-1733 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| United States, Louisiana | |
| CCOP - Ochsner | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Minnesota | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| Coborn Cancer Center | |
| Saint Cloud, Minnesota, United States, 56303 | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| United States, North Dakota | |
| Medcenter One Health System | |
| Bismarck, North Dakota, United States, 58501-5505 | |
| United States, Ohio | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45429 | |
| United States, South Carolina | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, South Dakota | |
| CCOP - Sioux Community Cancer Consortium | |
| Sioux Falls, South Dakota, United States, 57104 | |
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
| Study Chair: | Aminah Jatoi, MD | Mayo Clinic |
| Investigator: | Joanne M. Vanyo, MSN | Allegheny Cancer Center at Allegheny General Hospital |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00068731 History of Changes |
| Other Study ID Numbers: | CDR0000327843, NCCTG-N0351 |
| Study First Received: | September 10, 2003 |
| Last Updated: | November 13, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IV prostate cancer recurrent prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Lycopene Antioxidants |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Radiation-Protective Agents Anticarcinogenic Agents Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013