Radiosensitizing and Radioprotectve Effects of Curcumin in Prostate Cancer

N/ACompletedNCT01917890

Shahid Beheshti University of Medical Sciences40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Prostate Cancer Radiation Therapy

Interventions

Eligibility

Sex: MALEMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 1 year

Secondary Outcomes

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

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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.

Time frame: 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.

Time frame: 5 months

Radiosensitizing and Radioprotectve Effects of Curcumin in Prostate Cancer

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes