Clinical trial · Interventional
Docetaxel Plus Lycopene in Castration Resistant, Chemotherapy-Naïve Prostate Cancer Patients
A Phase II Study to Evaluate the Effects of Docetaxel Plus Lycopene in Castration Resistant, Chemotherapy-Naïve Prostate Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II trial evaluated the impact of giving docetaxel together with lycopene supplements in treating patients with hormone-resistant prostate cancer not previously treated with chemotherapy. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoprevention is the use of certain drugs, such as lycopene, to keep cancer from forming. Giving docetaxel together with lycopene may be an effective treatment for prostate cancer.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
| Recurrent Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Lycopene | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (docetaxel and lycopene)
- description
- Patients receive docetaxel IV over 1 hour on day 2 and lycopene PO once daily on days 1-21. Treatment repeats every 21days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Docetaxel
- Dietary Supplement: Lycopene
Primary outcomes (1)
- measure
- Proporation of Subjects Achieving Partial Response, Stable Disease or Progressive Disease Based on PSA Response Rates
- timeFrame
- Up to week 12 of therapy
- description
- To define the prostate-specific antigen (PSA) response rate according to the criteria of Bubley, et al. in subjects treated with a combination of docetaxel and lycopene. Per criteria of Bubley, et al., PSA response rate is defined the number of subjects who achieve a \>50% decline in PSA from baseline.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Patient must have a histological diagnosis of adenocarcinoma of the prostate and 2 rising pre-study PSA values \>= 1 ng/ml at least 1 week apart within 28 days prior to enrollment * Patients must be unresponsive to androgen-deprivation therapy (ADT), as indicated by a rising PSA level above the ADT nadir * Patient must not have received chemotherapy, biologic therapy, or any other investigational drug for any reason within 28 days prior to start of therapy, and must have recovered from toxicities of prior therapy to grade 1 or less * Patients must have been surgically or medically castrated; if the patient is being treated with medical castration, he must be willing to continue this treatment for the duration of the study; ADT should not be initiated, terminated, or dose-adjusted during the study * Prior external beam radiation therapy (to less than 30% of the bone marrow only) is allowed; at least 28 days must have elapsed since the completion of radiation therapy and the patient must have recovered from side effects; prior treatment with samarium-153 or strontium-86 is allowed if at least eight weeks have elapsed since dosing, and all toxicities have resolved to grade 1; soft tissue disease which has been radiated in the prior 2 months is not assessable as measurable disease * Patients may have received prior surgery; however, at least 21 days must have elapsed since completion of surgery and the patient must have recovered from all side effects * Normal serum bilirubin and serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvate transaminase (SGPT) =\< 1.5 x the institutional upper limit of normal obtained within 14 days prior to start of therapy; liver function tests should be evaluated prior to each treatment * Serum creatinine =\< 1.5 x the institutional upper limit of normal obtained within 14 days prior to start of therapy * Men of child bearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Absolute neutrophil count \>= 1,500/microliter (mcL) * Hemoglobin of \>= 8.0gm/dL * White blood cell count \> 2,500/mcL * Platelets \>= 100,000/mcL * Patients with lower values may participate if, in the opinion of the investigator, the cytopenias are the result of bone marrow involvement with active prostate cancer * Patients must be able to take oral medications * All patients must be informed and must sign and give written informed consent in accordance with institutional and federal guidelines; patients who are unable to comply with study and/or follow-up procedures are ineligible Exclusion Criteria: * Uncontrolled brain or spinal cord metastases * History of congestive heart failure or myocardial infarction within the previous six months * History of allergy or hypersensitivity to any component of the study drugs * Evidence or history of a bleeding diathesis or coagulopathy, including therapy-induced coagulopathy * Presence of chronic diarrhea (\> grade 1 by Common Toxicity Criteria (CTC)), short bowel syndrome, pancreatic insufficiency, or malabsorption * Presence of any severe or uncontrolled concurrent medical condition which, in the opinion of the investigator, would increase the risk of serious toxicity from the study drugs * Concurrent use of any vitamin, herb, or mineral supplements for at least 14 days prior to start of therapy
References
Publications (0)
Data not yet available