A study to Compare Quality of Life and side effects in patients undergoing Medical versus Surgical Castration in Metastatic Prostate cancer at Tata Memorial Hospital.
- Conditions
- Malignant neoplasm of prostate,
- Registration Number
- CTRI/2020/03/024111
- Lead Sponsor
- Tata Memorial Centre
- Brief Summary
Prostate cancer is one of the most common types of cancer in men. In case of Metastatic Prostate Cancer Patients, preferred option of treatment in the developed country is Medical Castration either by GnRH agonist or antagonist, but in case of India, majority of patients prefer undergoing surgical Orchiectomy taking into consideration the financial aspect of the patients in India.
Survival is an important endpoint in advanced Prostate Cancer, as is quality of life (QoL). The effects of the disease and its treatment on patient health-related QoL, plays an important role, when selecting the most appropriate treatment options. There are various side effects reported when it comes to patients undergoing surgical or medical castration as it causes sudden hormone changes in the body. Side effects from hormone changes may include sterility, loss of sexual interest, erection problems, hot flashes, weight gain, loss of muscle mass, [osteopo](https://www.uwhealth.org/health/topic/definition/osteoporosis/sto167501.html#sto167501-sec)rosis, fatigue, heart disease, memory problems.
Objective of the study is to compare quality of life of patients undergoing Medical versus Surgical Castration, at every 3 months till 2 year using FACT-P Questionnaire and to assess the side-effects and financial aspect of the patients in both the arms.
Patients with histologically proven metastatic prostate cancer, attending the OPDs of Uro-oncology DMG at Tata Memorial Hospital and willing to take treatment will be screened for the study. Informed consent form will be administered to the patient and patient will be explained about the study in detail. Patient will be enrolled in the study after he signs the informed consent form.
Patient after making the choice regarding the treatment options i.e. medical or surgical castration will be followed up during their regular OPD visits i.e. 3 monthly ±3 weeks for a period of 2 years and will be asked to fill a questionnaire FACT-P as per choice of their language, as FACT-P questionnaire is validated for English, Hindi, Marathi languages.
NOTE:
Sinceit is a non-randomized study, patient will receive treatment as per theirchoice. So, for the sake of assessment of toxicity, patients will be enrolledin each arm on time basis, i.e. number of metastatic prostate cancer patientscoming in Uro-Oncology DMG in 2 years will be enrolled (i.e. Approximately 300 in 2 years) and will be followed upfor 2 years, who will agree to undergo treatment and follow up at our centre.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Male
- Target Recruitment
- 300
-
- Patients with metastatic carcinoma prostate planned to receive either GnRH agonist / antagonist or surgical orchiectomy.
- 2)ECOG Criteria of 0,1,2.
-
- Patient willing to undergo treatment and follow up at our centre.
-
- Those not willing to comply with study procedures.
-
- Patients with performance status of 3,4.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the quality of life between the patients undergoing medical and surgical castration. 2 years
- Secondary Outcome Measures
Name Time Method 1.To compare the side effects between the patients undergoing medical and surgical castration. 2.To compare the expenditure of the treatments in the patients undergoing medical and surgical castration.
Trial Locations
- Locations (1)
Tata Memorial centre
🇮🇳(Suburban), MAHARASHTRA, India
Tata Memorial centre🇮🇳(Suburban), MAHARASHTRA, IndiaDr Amit JoshiPrincipal investigator022-24176229dramitjoshi74@gmail.com