Radiosensitizing and Radioprotectve Effects of Curcumin in Prostate Cancer

Study Overview
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Brief Summary
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Prostate cancer is the second most incident cancer among male population worldwide. Radiation therapy by itself or along with surgery and chemotherapy are the main treatments for prostate cancer however prostate cancer cells are only modestly responsive or even unresponsive to the cytotoxic effects of radiotherapy. Recently some in vitro and in vivo studies showed radiosensitizing and radioprotective effects for curcumin. No clinical trial has been done in this area and it is not yet known whether radiation therapy is more effective with or without curcumin supplements in treating patients with prostate cancer.

Official Title
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Radiation Therapy With or Without Curcumin Supplement in Treating Patients With Prostate Cancer

Conditions
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Prostate Cancer, Radiation Therapy

Intervention / Treatment
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* Dietary Supplement: Curcumin
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed adenocarcinoma of the prostate Age range of 50-80 ECOG performance status 0-1 Life expectancy > 5 years Must be enrolled in a social security program No other cancer, except basal cell skin cancer, that has been treated or relapsed within the past 5 years No severe uncontrolled hypertension (systolic BP ≥ 160 mm Hg or diastolic BP ≥ 90 mm Hg) No contraindication to luteinizing hormone-releasing hormone agonists No contraindication to pelvic irradiation (e.g., scleroderma, chronic inflammatory gastrointestinal disease) No hip prosthesis Must not be deprived of liberty or under guardianship No geographical, social, or psychological reasons that would preclude follow up Exclusion Criteria: Clinical stage T3 or T4 Gleason score ≥ 8 Serum PSA ≥ 20 ng/mL and ≤ 100 ng/mL other prior surgery for prostate cancer concurrent participation in another clinical trial which would require approval upon entry to this trial Gastrointestinal disorders such as IBD, reflux and peptic ulcers Any adverse reaction to curcumin

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Curcumin Group<br>Patients undergo 74 Gy of intensity-modulated radiotherapy 5 times a week for 7-8 weeks. Patients take 3 grams of curcumin (as 6 capsules 500 mg) | Dietary Supplement: Curcumin<br>* Patients undergo 74 Gy of intensity-modulated radiotherapy 5 times a week for 7-8 weeks. Patients take 3 grams of BCM95 Curcumin (as 6 × 500 mg capsules)<br>* Other names: turmeric pigment;|
| Placebo Comparator: Placebo<br>Patients undergo 74 Gy of intensity-modulated radiotherapy 5 times a week for 7-8 weeks. Patients take 3 grams of placebo (as 6 capsules 500 mg) | Dietary Supplement: Placebo<br>* Patients undergo 74 Gy of intensity-modulated radiotherapy 5 times a week for 7-8 weeks. Patients take 3 grams of roasted rice powder (as 6 × 500 mg capsules)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical or clinical progression-free survival | To assess this outcome the results of magnetic resonance spectroscopy (MRS)will be compared between the 2 groups 1 week before radiation therapy and 3 months after radiotherapy completion. Also prostate specific antigen (PSA)rebound will be compared between the 2 groups after 1 year. Side effects of treatment during 1 year after treatment completion will be compared between the 2 groups using questionnaires and physical examination | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Quality of life related issues will be compared between the 2 groups 1 week before radiotherapy onset and 3 months and 1 year after radiotherapy completion using EORTC QLQ-C30 and EORTC QLQ - PR25 | 1 year | 
| Sexual dysfunction score | Sexual dysfunction score will be compared between the 2 groups 1 week before radiotherapy onset and 3 months and 1 year after radiotherapy completion using EORTC QLQ - PR25 | 1 year | 
| C-reactive protein (hs-CRP) | It will be measured in plasma 1 week before radiotherapy onset and 3 month after radiotherapy completion using biochemical kits. (mg/L) | 5 months | 
| Inflammatory factors (tumor necrosis factor alpha (TNF-alpha), Interleukin 1 beta (IL1-beta)and Interleukin 6 (ILl-6)) | They will be measured in plasma 1 week before radiotherapy onset and 3 month after radiotherapy completion using biochemical kits. (pg/ml) | 5 monthes | 
| Antioxidant enzymes (Catalase, super oxide dismutase (SOD), glutathione-S- transferase (GST), glutathione peroxidase (GPX)) | They will be measured in plasma 1 week before radiotherapy onset and 3 month after radiotherapy completion using biochemical kits. (U/L) | 5 months | 
| cycloxygenase 2 (COX2) | measuring activity and gene expression of the enzyme in peripheral blood mono-nuclear cell (PBMC)1 week before radiotherapy onset and 3 months after radiotherapy. | 5 months | 
| Nuclear factor KB (NF-ΚB) | measuring activity and gene expression in peripheral blood mono-nuclear cell (PBMC)1 week before radiotherapy onset and 3 months after radiotherapy. | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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curcumin, radioprotective, radiosensitizer