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

Prostate Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02960087
• Other study ID #: PR19
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2017
• Est. completion date: March 31, 2029

Study information

• Verified date: March 2024
• Source: Canadian Cancer Trials Group
• Contact: Wendy Parulekar
• Phone: 613-533-6430
• Email: wparulekar[@]ctg.queensu.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 232
• Est. completion date: March 31, 2029
• Est. primary completion date: September 30, 2028
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

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 localized prostate cancer are eligible according to the following

guidelines:

• TNM classification:
• Clinical stage T1-T2 and Gleason 6 and PSA <20 ng/mL
• Clinical stage T1-T2 and Gleason 7 (3+4) and PSA < 15 ng/mL and = 50% of positive nontargeted cores in patients who undergo systematic biopsy
• 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).

Related Conditions & MeSH terms

• Prostate Carcinoma
• Prostatic Neoplasms

Intervention

Radiation:
• Low dose rate brachytherapy
I-125 to a total dose of 144 Gy
• High dose rate brachytherapy
27 Gy in 2 fractions

Locations

Country	Name	City	State
Canada	CHUM-Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	The Jewish General Hospital	Montreal	Quebec
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario
Canada	Hotel-Dieu de Quebec	Quebec City	Quebec
Canada	Odette Cancer Centre	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Canadian Cancer Trials Group

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Establish a comprehensive tumour bank linked to a clinical database for further studies of predictive and prognostic biomarkers in prostate cancer		7 years
Other	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		7 years
Other	PSA nadir - Date PSA nadir +2 ng/ml is reached		7 years
Other	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		7 years
Other	Regional disease progression - Prostate cancer progression involving the lymph nodes below the bifurcation of the common iliac arteries.		7 years
Other	Distant disease progression - Evidence of prostate cancer by radiology or cytology or histology at sites remote from the prostate		7 years
Primary	Efficacy of HDR and LDR brachytherapy on prostate cancer control as defined by 48 month PSA values	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	48 months
Secondary	Disease-free survival		7 years
Secondary	Number and severity of adverse events	Acute and long term toxicity and safety including lower urinary tract symptoms	7 years
Secondary	Quality of Life of patient and partner utilizing EPIC, PROMIS and R-DAS fatigue short form		7 years
Secondary	Economic Analysis	Resource utilization and economic indices of treatment administration	7 years