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NCT Number: NCT01917890

Radiosensitizing and Radioprotectve Effects of Curcumin in Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Radiation Therapy Urogenital Diseases Urogenital Neoplasms

Age range

50 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Oncology and radiotherapy department, Besat Hospital

Tehran, Tehran Province, 556432412, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Curcumin

Dietary Supplement

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)

Other names: turmeric pigment

Placebo

Dietary Supplement

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)

Primary outcomes

  1. Biochemical or clinical progression-free survival

    Time frame: 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 outcomes

  1. Quality of life

    Time frame: 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

  2. Sexual dysfunction score

    Time frame: 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

  3. C-reactive protein (hs-CRP)

    Time frame: 5 months

    It will be measured in plasma 1 week before radiotherapy onset and 3 month after radiotherapy completion using biochemical kits. (mg/L)

  4. Inflammatory factors (tumor necrosis factor alpha (TNF-alpha), Interleukin 1 beta (IL1-beta)and Interleukin 6 (ILl-6))

    Time frame: 5 monthes

    They will be measured in plasma 1 week before radiotherapy onset and 3 month after radiotherapy completion using biochemical kits. (pg/ml)

  5. Antioxidant enzymes (Catalase, super oxide dismutase (SOD), glutathione-S- transferase (GST), glutathione peroxidase (GPX))

    Time frame: 5 months

    They will be measured in plasma 1 week before radiotherapy onset and 3 month after radiotherapy completion using biochemical kits. (U/L)

  6. cycloxygenase 2 (COX2)

    Time frame: 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.

  7. Nuclear factor KB (NF-ΚB)

    Time frame: 5 months

    measuring activity and gene expression in peripheral blood mono-nuclear cell (PBMC)1 week before radiotherapy onset and 3 months after radiotherapy.

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 7, 2013
Registry last updated
Nov 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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