Brief Summary
Whole gland LDR brachytherapya type of internal radiation therapy where radioactive material is placed inside or near a tumor to deliver targeted radiation has been a well established modality of treating low riskthe possibility that something bad will happen prostatea walnut-shaped gland in the male reproductive system that is responsible for producing semen - a bodily fluid that acts as a vessel for sperm transport during ejaculation cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs. Treatment in a focal manner has the advantages of reduced toxicity to surrounding organs.
AIM: To determine the utility of focal LDR brachytherapy in form of hemiablative treatment for localized prostate cancer demonstrating the feasibility of the delivery of the prescription dosethe amount of medication taken to the half of the prostate in terms of meeting standard dosimetric parameters while respecting same or lower tolerance doses of adjacent normal organs.
To determine acutenew, recent, comes with an urgent or significant sense, is sudden, sharp and late rectal, urinary and sexual toxicity after this procedure.
To assess the change from baseline in QOL indicators at specific time intervals using validated international questionnaires [International Prostate Symptom Score ( IPSS), International Index of Erectile Function ( IIEF ), Expanded Prostate Cancer Index (EPIC)] after this treatment.
To evaluate the local tumoura tissue mass that forms from groups of unhealthy cells control in terms of biopsyremoval of a section of tissue to analyse for cancer cells outcomes after focal brachytherapy 36 months after the treatment.
To compare target coverage and relative doses to the rectumthe last section of the large intestine/bowel that holds waste until it is ready to be removed from the body and the urethrathe tube that carries urine from the bladder to outside of the body for the same patient performing a hemigland treatment planning vs Whole gland treatment planning.
STUDY DESIGN: Multi-institution prospective trial to determine whether hemiablative treatment with LDR for prostate cancer is dosimetrically safe and feasible.This study will record data for 20 patients with ipsilateral with low and low tier intermediate risk disease.The study will record quality of lifethe overall well-being of a person diagnosed with cancer, encompassing both physical and emotional aspects of health parameters in particular in terms of urinary, rectal and sexual function side effects.
INTERVENTION:
- Baseline Transperineal Template guided mapping prostate biopsy with >20 cores (not required if already performed)
- Multiparametric MRI within the 3 months prior to registration and at 18 & 36 months.
- Hemigland prostate region will be targeted with the prescription dose and receive 144 Gy of Iodine125 (I125).
- The quality of life assessment will focus on erectile function, urinary function, bowelportion of the digestive system that digests food (small bowel) and absorbs salts and water (large bowel); also called intestines function, and general health related quality of life
- Postimplant CT Planning day 30 after the implant for quality assurance.
MEASUREMENT OF ENDPOINTS :
Dosimetric parameters record, Toxicity and QOL evaluation forms, PSA follow up and biopsies at 36 months to assess local control.
Intervention / Treatment
- Radiation: Transperineal template guided mapping biopsy, multiparametric MRI, Hemiablative Focal Brachytherapy
Inclusion Criteria
- 1. Patients must have histologically proven adenocarcinomacancer arising from mucus-producing glands in organs of the prostate.2. Patients must have low or low-tier intermediate prostate cancer
- Low risk prostate cancer patients must have:
- Clinical stage ≤ T2a,
- Gleason score =6 and iPSA ≤ 10 ng/ml
- < 25% cores positive, < 50 % cancer in each core involved
- Low tier Intermediate risk patients may have:
- Clinical stageT2a
- Gleason score ≤ 3+4=7
- PSA ≤ 10 ng/ml
- < 25% cores positive, < 50 % cancer in each core3. Patients must be fit for general anesthetic. 4. Patients must have unilateralaffecting one side disease on biopsy 5. Patients must have an Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0 – 2.
6. Men ≥ 65 years of age with a life expectancy estimated to be >10 years. 7. Patients must have no contraindications to interstitial prostate brachytherapy.
8. Patients on anticoagulantmedication used to prevent or reduce blood clots; also known as blood thinners therapy must be able to stop therapy safely for at least 7 days.
9. Patients must not have any contraindications to MRI 10. IPSS <=16
- Low risk prostate cancer patients must have: