LDR vs. HDR Brachytherapy for Prostate Cancer

Prostate Cancer Clinical Trial

— LDR/HDRmono  

Official title:

A Phase III Randomized Study of Low Dose Rate Compared to High Dose Rate Prostate Brachytherapy for Favorable Risk and Low Tier Intermediate Risk Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03426748
• Other study ID #: H17-02904
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2018
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2023
• Source: British Columbia Cancer Agency
• Contact: Juanita M Crook, MD
• Phone: 250 712 3958
• Email: jcrook[@]bccancer.bc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

H17-02904 is a randomized comparison of low dose rate vs. high dose rate prostate brachytherapy for favorable and intermediate risk prostate cancer suitable for brachytherapy as monotherapy. This is a continuation with expanded accrual of the randomized Pilot study H15-02103

Description:

Men suitable for prostate brachytherapy as monotherapy will undergo multiparametric Magnetic Resonance Imaging for staging and identification of a dominant lesion and will be randomly selected for either a single low dose rate permanent seed implant or 2 fractions of high dose rate brachytherapy. Using image registration techniques, dominant lesions will be biopsied under anesthesia at the start of the brachytherapy procedure. Biopsies will reviewed for tumor Gleason score and sent for Cell Cycle Progression testing (Prolaris). Patients receiving high dose rate brachytherapy will also have biopsies between the 2 fractions to assess tumor changes induced from the first fraction. Post implant quality assurance will determine the dose to the dominant lesions and compare these between the 2 types of brachytherapy. Post implant symptoms will be tracked for severity and time course.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

Favorable risk and low-tier intermediate-risk prostate cancer with estimated life expectancy of at least 10 years.

• Clinical stage T1c-T2b, PSA < 20, Gleason < 8
• ECOG 0-1
• Low tier intermediate-risk prostate cancer is defined by a single NCCN intermediate risk factor
• Extensive favorable-risk disease is defined as:
• clinical stage T1c-T2a
• PSA < 10
• Gleason 6
• = 50% of biopsy cores containing cancer
• PSA density > 0.2 ng/cc
• Selected intermediate risk patients not defined above
• - T1c/T2a
• - PSA < 10
• -Gleason 4+3
• -< 33% of cores involved
• -Max tumor length in any core 10 mm
• No androgen deprivation therapy (ADT)
• Prostate volume by TRUS = 60 cc.
• Not eligible for, or accepting of, active surveillance according to NCCN guidelines.
• Signed study specific informed consent.

Exclusion Criteria:

• Prior radical surgery for carcinoma of the prostate,
• Prior pelvic radiation
• Prior chemotherapy for prostate cancer,
• Prior TURP or cryosurgery of the prostate
• Claustrophobic or unable to undergo MRI

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Low dose rate prostate brachytherapy
Permanent implantation of radioactive Iodine-125 seeds under anesthesia with ultrasound guidance
• High dose rate prostate brachytherapy
Temporary implantation of radioactive material into the prostate in the form of a stepping source of Iridium 192 that travels through 16-18 needles or catheters strategically placed through the prostate

Locations

Country	Name	City	State
Canada	British Columbia Cancer Agency Center for the Southern Interior	Kelowna	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
British Columbia Cancer Agency	BC Cancer Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Batchelar D, Gaztanaga M, Schmid M, Araujo C, Bachand F, Crook J. Validation study of ultrasound-based high-dose-rate prostate brachytherapy planning compared with CT-based planning. Brachytherapy. 2014 Jan-Feb;13(1):75-9. doi: 10.1016/j.brachy.2013.08.004. Epub 2013 Sep 27. — View Citation

Crook J, Ots A, Gaztanaga M, Schmid M, Araujo C, Hilts M, Batchelar D, Parker B, Bachand F, Milette MP. Ultrasound-planned high-dose-rate prostate brachytherapy: dose painting to the dominant intraprostatic lesion. Brachytherapy. 2014 Sep-Oct;13(5):433-41. doi: 10.1016/j.brachy.2014.05.006. Epub 2014 Jun 20. — View Citation

Schmid M, Crook JM, Batchelar D, Araujo C, Petrik D, Kim D, Halperin R. A phantom study to assess accuracy of needle identification in real-time planning of ultrasound-guided high-dose-rate prostate implants. Brachytherapy. 2013 Jan-Feb;12(1):56-64. doi: 10.1016/j.brachy.2012.03.002. Epub 2012 Apr 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in Quality of Life in the urinary domain between LDR and HDR brachytherapy.	The urinary domain of the EPIC prostate cancer specific QOL questionnaire will be assessed.	0-36 months
Secondary	Quality of Life in the bowel and sexual domains	The EPIC score in the bowel and sexual domains will be evaluated at baseline, 1, 3, 6, 12, 24 and 36 months	0-36 months
Secondary	Time to return to baseline +/- 3 points for the International Prostate Symptom Score	The IPS Score will be assessed at baseline, 1, 3, 6, 12, 24 and 36 months	0-36 months
Secondary	Acute and long term toxicity	Acute and long-term toxicity will be graded using the Common Terminology Criteria for Adverse Events (CTCAE V4) at each follow up time point	[Time Frame: 0-10 years]
Secondary	Biochemical Outcome	PSA will be recorded every 6 months to 5 years and then annually to 10 years	5-10 years
Secondary	Histologic Outcome	Prostate re-biopsy will be performed at 36 months to assess the local efficacy of treatment	3 years
Secondary	Cell cycle progression score	For those patients consenting to targeted biopsies under anesthesia at the start of their brachytherapy procedure (separate optional consent) MRI-TRUS fusion accuracy will be verified by targeted biopsies and Biopsy material will be sent for genetic testing to determine Cell cycle Progression scores for both arms of the trial to ultimately correlate with outcome.	1 month to 10 years
Secondary	Tumor oxygenation and cell cycle distribution	For patients receiving 2 fractions of high dose rate brachytherapy, biopsy between the 2 fractions will assess radiosensitivity by evaluating changes in oxygenation and cell cycle distribution between the 2 fractions, for ultimate correlation with efficacy	1 month to 10 years.