Prostate Cancer, Radiation Therapy
Conditions
Keywords
curcumin, radioprotective, radiosensitizer
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTCurcumin
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)
DIETARY_SUPPLEMENTPlacebo
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)
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed adenocarcinoma of the prostate 2. Age range of 50-80 3. ECOG performance status 0-1 4. Life expectancy \> 5 years 5. Must be enrolled in a social security program 6. No other cancer, except basal cell skin cancer, that has been treated or relapsed within the past 5 years 7. No severe uncontrolled hypertension (systolic BP ≥ 160 mm Hg or diastolic BP ≥ 90 mm Hg) 8. No contraindication to luteinizing hormone-releasing hormone agonists 9. No contraindication to pelvic irradiation (e.g., scleroderma, chronic inflammatory gastrointestinal disease) 10. No hip prosthesis 11. Must not be deprived of liberty or under guardianship 12. No geographical, social, or psychological reasons that would preclude follow up
Exclusion criteria
1. Clinical stage T3 or T4 2. Gleason score ≥ 8 3. Serum PSA ≥ 20 ng/mL and ≤ 100 ng/mL 4. other prior surgery for prostate cancer 5. concurrent participation in another clinical trial which would require approval upon entry to this trial 6. Gastrointestinal disorders such as IBD, reflux and peptic ulcers 7. Any adverse reaction to curcumin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical or clinical progression-free survival | 1 year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sexual dysfunction score | 1 year | 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 |
| C-reactive protein (hs-CRP) | 5 months | It will be measured in plasma 1 week before radiotherapy onset and 3 month after radiotherapy completion using biochemical kits. (mg/L) |
| Inflammatory factors (tumor necrosis factor alpha (TNF-alpha), Interleukin 1 beta (IL1-beta)and Interleukin 6 (ILl-6)) | 5 monthes | They will be measured in plasma 1 week before radiotherapy onset and 3 month after radiotherapy completion using biochemical kits. (pg/ml) |
| Quality of life | 1 year | 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 |
| cycloxygenase 2 (COX2) | 5 months | 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. |
| Nuclear factor KB (NF-ΚB) | 5 months | measuring activity and gene expression in peripheral blood mono-nuclear cell (PBMC)1 week before radiotherapy onset and 3 months after radiotherapy. |
| Antioxidant enzymes (Catalase, super oxide dismutase (SOD), glutathione-S- transferase (GST), glutathione peroxidase (GPX)) | 5 months | They will be measured in plasma 1 week before radiotherapy onset and 3 month after radiotherapy completion using biochemical kits. (U/L) |
Countries
Iran
Outcome results
None listed