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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02960087
Recruitment Status : Recruiting
First Posted : November 9, 2016
Last Update Posted : February 15, 2022
Information provided by (Responsible Party):
Canadian Cancer Trials Group

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

Condition or disease Intervention/treatment Phase
Prostate Carcinoma Radiation: Low dose rate brachytherapy Radiation: High dose rate brachytherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial Evaluating High Dose Rate Brachytherapy and Low Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer
Actual Study Start Date : November 4, 2016
Estimated Primary Completion Date : September 30, 2027
Estimated Study Completion Date : March 31, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Active Comparator: Arm 1 LDR
Low Dose Rate (LDR) brachytherapy with I-125 to a total dose of 144 Gy
Radiation: 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 fractions
Radiation: High dose rate brachytherapy
27 Gy in 2 fractions

Primary Outcome Measures :
  1. Efficacy of HDR and LDR brachytherapy on prostate cancer control as defined by 48 month PSA values [ Time Frame: 48 months ]
    The 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 arm

Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: 7 years ]
  2. Number and severity of adverse events [ Time Frame: 7 years ]
    Acute and long term toxicity and safety including lower urinary tract symptoms

  3. Quality of Life of patient and partner utilizing EPIC, PROMIS and R-DAS fatigue short form [ Time Frame: 7 years ]
  4. Economic Analysis [ Time Frame: 7 years ]
    Resource utilization and economic indices of treatment administration

Other Outcome Measures:
  1. Establish a comprehensive tumour bank linked to a clinical database for further studies of predictive and prognostic biomarkers in prostate cancer [ Time Frame: 7 years ]
  2. 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 bounce [ Time Frame: 7 years ]
  3. PSA nadir - Date PSA nadir +2 ng/ml is reached [ Time Frame: 7 years ]
  4. 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 malignancy [ Time Frame: 7 years ]
  5. Regional disease progression - Prostate cancer progression involving the lymph nodes below the bifurcation of the common iliac arteries. [ Time Frame: 7 years ]
  6. Distant disease progression - Evidence of prostate cancer by radiology or cytology or histology at sites remote from the prostate [ Time Frame: 7 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02960087

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Contact: Wendy Parulekar 613-533-6430

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Canada, Ontario
Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Alain Haddad    613 737-7700 ext 25395      
Odette Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Gerard Morton    416 480-6165      
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Joelle Helou    416 946-4483      
Canada, Quebec
CHUM-Centre Hospitalier de l'Universite de Montreal Recruiting
Montreal, Quebec, Canada, H2X 3E4
Contact: Maroie Barkati    514 890-8254      
The Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: M. Tamim Niazi    514 340-8288      
Hotel-Dieu de Quebec Recruiting
Quebec City, Quebec, Canada, G1R 2J6
Contact: Eric Vigneault    418 691-5264      
Sponsors and Collaborators
Canadian Cancer Trials Group
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Study Chair: Gerard Morton Sunnybrook Health Sciences, Toronto ON
Study Chair: Eric Vigneault Hotel Dieu de Quebec, Montreal, QC
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Responsible Party: Canadian Cancer Trials Group Identifier: NCT02960087    
Other Study ID Numbers: PR19
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: February 15, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases