Cancer, Prostate Cancer

Not Applicable

Interventional Study

Phase II High Dose Brachytherapy and Low Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer

Sponsor

Canadian Cancer Trials Group

Start Date

04/11/2016

Completion Date

30/09/2027

Sex

MEN

Enrollment

232

Ages From

18

Healthy Volunteers?

Yes

Contact

Wendy Parulekar

Location

Ottawa Hospital Research Institute

Trial Details

Brief Summary

The purpose of this study is to evaluate the dose of High Dose Rate (HDR) brachytherapy chosen for this study as well as a commonly used alternate form of brachytherapy called low dose rate (or seed) brachytherapy. Investigators would like to understand how these treatments control the prostate cancer and look at their short and long term treatment related side effects. The dose of radiation for HDR brachytherapy for this study has been changed since the study started. Other studies using the dose of radiation for HDR brachytherapy that was originally chosen for this study (Arm 2) found that this dose of radiation may be linked to a greater chance of the cancer coming back in the prostate. Therefore since March 2020, for new participants entering the study, a new HDR brachytherapy arm with a higher amount of radiation given over two doses will be tested in this study

Official Title

A Randomized Phase II Trial Evaluating High Dose Rate Brachytherapy and Low Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer

Detailed Description

Radiation therapy is an accepted treatment to help manage low and intermediate risk prostate cancer. Radiation therapy can be given using machines that are outside the body (called “image guided external beam radiation therapy”) or by brachytherapy, which is a form of radiation therapy where the radiation source is placed directly into the prostate gland near the tumour. The standard or usual treatments for low or intermediate risk prostate cancer are low dose-rate (LDR) brachytherapy which involves placing radioactive seeds in the prostate which deliver radiation over several months, image guided external beam radiation therapy (IGRT), or IGRT plus high dose-rate (HDR) brachytherapy boost.

High Dose-Rate (HDR) brachytherapy is another type of brachytherapy which delivers a high dose of radiation to the tumour over a period of minutes. The radiation is delivered under computer control through flexible needles, which are temporarily inserted into the prostate. This form of radiotherapy targets cancer cells within the prostate gland. HDR brachytherapy is another type of radiotherapy for prostate cancer that has the potential to help target your cancer more accurately while causing fewer side effects compared with standard radiation therapy. HDR brachytherapy is an option for treatment in some hospitals now but the best dose of radiation is still unknown. This study is testing a new dose of radiation for HDR brachytherapy.

Selection Criteria

Eligibility Inclusion Criteria

Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 9 months. Patients on active surveillance with evidence of disease progression are eligible to the protocol as long as they meet the eligibility criteria and have a recent prostate biopsy (within 9 months).
Patients with low or intermediate risk prostate cancer are eligible according to the following guidelines:

• TNM classification:

Clinical stage T1-T2 and Gleason 6 and PSA <20 ng/mL (Low risk)
Clinical stage T1-T2 and Gleason 7 (3+4) and PSA < 15 ng/mL and ≤ 50% of positive cores (Intermediate risk)
Eastern Cooperative Oncology Group status 0-1.
Bone scan and pelvic CT scan/MRI within the last 6 months at the discretion of the treating physician.
Patient must be ≥ 18 years of age.
Judged to be medically fit for brachytherapy.
Prostate volume by Trans-rectal Ultrasound (TRUS) or Magnetic Resonance Imaging (MRI) ≤ 60 cc within the last 6 months.
American Urological Association (AUA) score ≤ 20 (alpha blockers allowed) within the last 4 weeks.
Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French.
Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrolment in the trial to document their willingness to participate.
Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre.
In accordance with CCTG policy, protocol treatment is to begin within 12 weeks of patient randomization.
Patients must be willing to take precautions to prevent pregnancy while on study.
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

Eligibility Exclusion Criteria

Prior or current bleeding diathesis.
Previous androgen deprivation therapy (ADT).
Alpha-reductase inhibitors (ARIs) within 90 days of randomization.
Radical surgery for carcinoma of the prostate, prior pelvic radiation, prior chemotherapy for prostate cancer, prior TURP, prior cryosurgery of the prostate.
Evidence of metastatic disease (radiology investigations at the discretion of the treating physician).
Any serious active or co-morbid medical conditions, laboratory abnormality, psychiatric illness, active or uncontrolled infections, or serious illnesses or medical conditions that would prevent the patient from participating or to be managed according to the protocol (according to investigator's decision).

ARMS & Interventions

PARTICIPANT GROUP ARMINTERVENTION TREATMENT
Active Comparator: Arm 1 LDR Low Dose Rate (LDR) brachytherapy with I-125 to a total dose of 144 GyRadiation: Low dose rate brachytherapy I-125 to a total dose of 144 Gy
Active Comparator: Arm 3 HDR High Dose Rate brachytherapy: 27 Gy in 2 fractionsRadiation: High dose rate brachytherapy 27 Gy in 2 fractions

Primary Outcome

MeasuresMeasure DescriptionMEASURE TIME FRAME
Efficacy of HDR and LDR brachytherapy on prostate cancer control as defined by 48 month PSA valuesThe primary endpoint of the study is prostate cancer control rate at 48 months. It is defined as the PSA <0.4ng/ml at 48 months. One sample binomial test will be used to test the 48 months disease control rate for each arm48 months

Secondary Outcome

MEASURESMEASURE DESCRIPTIONMEASURE TIME FRAME
Disease-free survival7 years
Number and severity of adverse eventsAcute and long term toxicity and safety including lower urinary tract symptoms7 years
Quality of Life of patient and partner utilizing EPIC, PROMIS and R-DAS fatigue short form7 years
Economic AnalysisResource utilization and economic indices of treatment administration7 years

Other Outcome

MEASURESMEASURE DESCRIPTIONMEASURE TIME FRAME
Establish a comprehensive tumour bank linked to a clinical database for further studies of predictive and prognostic biomarkers in prostate cancer7 years
PSA Progression - PSA nadir +2 ng/ml will be used to define biochemical failure and can only be declared at 36 months or beyond due to the phenomenon of PSA bounce7 years
PSA nadir - Date PSA nadir +2 ng/ml is reached7 years
Local disease progression - Clinically suspicious change in DRE with biopsy confirmation of progression or Urethral obstruction or bleeding necessitating a trans-urethral resection (TURP) only if resected tissue demonstrates malignancy7 years
Regional disease progression - Prostate cancer progression involving the lymph nodes below the bifurcation of the common iliac arteries.7 years
Distant disease progression - Evidence of prostate cancer by radiology or cytology or histology at sites remote from the prostate7 years

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