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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02643511




Registration number
NCT02643511
Ethics application status
Date submitted
22/07/2015
Date registered
31/12/2015
Date last updated
31/12/2015

Titles & IDs
Public title
Hemiablative Focal Brachytherapy Pilot Study
Scientific title
Focal Low Dose Rate ( LDR) Brachytherapy: Hemi-ablative Treatment With LDR for Patients With Low and Low-tier Intermediate Risk Prostate Cancer
Secondary ID [1] 0 0
STGAF
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Transperineal template guided mapping biopsy, multiparametric MRI, Hemiablative Focal Brachytherapy

Experimental: Prostate biopsy,Hemiablative focal Brachytherapy - This is a non-randomized, Phase II study examining the efficacy in terms of postimplant dosimetry (primary endpoint) as well as the secondary endpoints of QOL changes, toxicity, local control with post-treatment biopsy outcomes and comparison with historical whole-gland cohorts in men with early stage low volume prostate cancer treated with hemiablative focal brachytherapy


Treatment: Other: Transperineal template guided mapping biopsy, multiparametric MRI, Hemiablative Focal Brachytherapy
A re-staging transperineal template guided mapping prostate biopsy as currently performed at participating institutions. Hemiablative Focal brachytherapy will be performed . The affected half of the prostate will be targeted with the prescription dose and receive 145 Gy of Iodine-125 (I-125). A postimplant dosimetry will be performed 30 days after procedure. The quality-of-life assessment will focus on erectile function, urinary function, bowel function, and general health related quality of life. The patients will complete this assessment at baseline and then 4 weeks, 6 months, 12 months, 20 months, 24 months, 32 months and 36 months after treatment. A second transperineal biopsy will be performed 36 months after the implant.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Optimal dosimetric parameters to target and organs at risk in day 30 postimplant dosimetry
Timepoint [1] 0 0
1month to 3 years
Secondary outcome [1] 0 0
Rates of acute and late toxicity assessed by CTCAE v4.0
Timepoint [1] 0 0
6months to 10years
Secondary outcome [2] 0 0
Change from baseline in QOL in Genitourinary aspect
Timepoint [2] 0 0
6 months to 10 years
Secondary outcome [3] 0 0
Change from baseline in QOL in the sexual aspect
Timepoint [3] 0 0
6 months to 10 years
Secondary outcome [4] 0 0
Change from baseline in QOL in the gastrointestinal aspect
Timepoint [4] 0 0
6 months to 10 years
Secondary outcome [5] 0 0
Local control as Negative prostate biopsy 36 months after the treatment
Timepoint [5] 0 0
3 years after treatment
Secondary outcome [6] 0 0
Dosimetric parameters comparison between hemigland treatment vs Whole gland historical cohort
Timepoint [6] 0 0
6 months to 10 years
Secondary outcome [7] 0 0
Grade of genitourinary and gastrointestinal toxicity assessed by CTCAE v4.0 comparison between hemigland treatment vs Whole gland historical cohort
Timepoint [7] 0 0
6 months to 10 years

Eligibility
Key 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
Minimum age
60 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St George Hospital Cancer Care Centre - Kogarah, Sydney
Recruitment postcode(s) [1] 0 0
2217 - Kogarah, Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
St George Hospital, Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02643511
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ana Fernandez, MD
Address 0 0
Country 0 0
Phone 0 0
+61291131306
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02643511