Prostate Cancer Clinical Trial
Official title:
Focal Low Dose Rate ( LDR) Brachytherapy: Hemi-ablative Treatment With LDR for Patients With Low and Low-tier Intermediate Risk Prostate Cancer
Whole gland LDR brachytherapy has been a well established modality of treating low risk
prostate cancer. 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 dose 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 acute 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 tumour control in terms of biopsy outcomes after focal brachytherapy
36 months after the treatment.
To compare target coverage and relative doses to the rectum and the urethra 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 life 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, bowel
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | July 2025 |
Est. primary completion date | July 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - 1. Patients must have histologically proven adenocarcinoma 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 core 3. Patients must be fit for general anesthetic. 4. Patients must have unilateral disease on biopsy 5. Patients must have an Eastern Cooperative Oncology 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 anticoagulant 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 Exclusion Criteria: 1. Does not meet staging criteria for low risk or low tier intermediate risk prostate cancer 2. Bilateral prostatic disease 3. Prior hormonal therapy 4. Prior Transurethral resection or middle lobe resection 5. Recent IPSS> 6. Unfit for general anesthetic 7. MRI contraindicated 8. Unable to cease anticoagulant therapy 9. Life expectancy < 10 years 10. IPSS>16 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | St George Hospital Cancer Care Centre | Kogarah, Sydney | New South Wales |
Lead Sponsor | Collaborator |
---|---|
St George Hospital, Australia |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Optimal dosimetric parameters to target and organs at risk in day 30 postimplant dosimetry | Acceptable dosimetric parameters in Day 30 postimplant dosimetry as per brachytherapy guidelines | 1month to 3 years | Yes |
Secondary | Rates of acute and late toxicity assessed by CTCAE v4.0 | Treatment related toxicities will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | 6months to 10years | Yes |
Secondary | Change from baseline in QOL in Genitourinary aspect | This will be assessed using the IPSS questionnaire | 6 months to 10 years | No |
Secondary | Change from baseline in QOL in the sexual aspect | This will be assessed using the IIEF questionnaire | 6 months to 10 years | No |
Secondary | Change from baseline in QOL in the gastrointestinal aspect | This will be assessed using the EPIC questionnaire | 6 months to 10 years | No |
Secondary | Local control as Negative prostate biopsy 36 months after the treatment | 3 years after treatment | Yes | |
Secondary | Dosimetric parameters comparison between hemigland treatment vs Whole gland historical cohort | 6 months to 10 years | No | |
Secondary | Grade of genitourinary and gastrointestinal toxicity assessed by CTCAE v4.0 comparison between hemigland treatment vs Whole gland historical cohort | 6 months to 10 years | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05540392 -
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
|
Phase 1/Phase 2 | |
Recruiting |
NCT05613023 -
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
|
Phase 3 | |
Recruiting |
NCT05156424 -
A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03177759 -
Living With Prostate Cancer (LPC)
|
||
Completed |
NCT01331083 -
A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05540782 -
A Study of Cognitive Health in Survivors of Prostate Cancer
|
||
Active, not recruiting |
NCT04742361 -
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
|
Phase 3 | |
Completed |
NCT04400656 -
PROState Pathway Embedded Comparative Trial
|
||
Completed |
NCT02282644 -
Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
|
N/A | |
Recruiting |
NCT06305832 -
Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT05761093 -
Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
|
||
Completed |
NCT04838626 -
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
|
Phase 2/Phase 3 | |
Recruiting |
NCT03101176 -
Multiparametric Ultrasound Imaging in Prostate Cancer
|
N/A | |
Completed |
NCT03290417 -
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
|
N/A | |
Active, not recruiting |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Completed |
NCT01497925 -
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT03679819 -
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
|
||
Completed |
NCT03554317 -
COMbination of Bipolar Androgen Therapy and Nivolumab
|
Phase 2 | |
Completed |
NCT03271502 -
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
|
N/A |