Feasibility Trial Of Image Guided External Beam Radiotherapy With Or Without High Dose Rate Brachytherapy Boost In Men With Intermediate-Risk Prostate Cancer

Study Overview
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Brief Summary
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This research is being done because investigators involved in this study would like to compare image guided external beam radiation therapy (IGRT) to IGRT plus HDR brachytherapy boost to see which treatment is better and what the side effects of treatment are.

Detailed Description
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Before a big study is done, a smaller study (called a feasibility study) is required to make sure that patients and physicians are willing to participate in a study comparing the two kinds of treatments, and to verify how the radiation therapy is given in different centres across Canada. The standard or usual treatment for this disease includes treatment with IGRT or IGRT plus HDR brachytherapy boost.

Official Title
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Randomized Phase II Feasibility Trial Of Image Guided External Beam Radiotherapy With Or Without High Dose Rate Brachytherapy Boost In Men With Intermediate-Risk Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Image guided external beam radiotherapy with or without brachytherapy boost
* Radiation: Brachytherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed prostate adenocarcinoma. The date of the last biopsy that verifies that the eligibility criterions have been met must be within 9 months prior to randomization. There must be no prior treatment. Intermediate-risk cancer patients based on the NCCN Guidelines (www.nccn.org): • TNM classification: T2b-T2c and Gleason Score < 8/10 and PSA < 20 ng/ml; or T1c-T2a and Gleason Score 7/10 and PSA < 20 ng/ml; or T1c-T2a and Gleason Score ≤ 6/10 and 10 ≤ PSA < 20 ng/ml For patients who have been on alpha reductase inhibitors within the last 6 months, use the following guidelines: T2b-T2c and Gleason Score < 8/10 and PSA ≤ 10 ng/ml; or T1c-T2a and Gleason Score 7/10 and PSA ≤ 10 ng/ml; or T1c-T2a and Gleason Score ≤ 6/10 and 5 ≤ PSA ≤ 10 ng/ml No alpha reductase inhibitors (i.e. avodart, proscar) use within 2 weeks of randomization. A washout period of 2 weeks is required prior to randomization. Prostate volume ≤ 75 cc. American Urological Association (AUA) Symptom Index score < 20. Judged to be medically fit for IGRT and HDR brachytherapy boost by a radiation oncologist. ECOG Performance Status of 0 or 1. ≥ 18 years of age. 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. This implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial. Investigators must assure themselves the patients registered on this trial will be available for complete documentation of the treatment, adverse events, and follow-up. Protocol treatment is to begin within 4 weeks of patient randomization. HDR brachytherapy boost treatment is to begin within 3 weeks before or after IGRT for those randomized to Arm 2. Participants must be willing to take precautions to prevent pregnancy while on treatment. In addition to routine contraceptive methods, effective contraception also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention). However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures, he is responsible for beginning contraceptive measures. Exclusion Criteria: History of transurethral resection of the prostate (TURP). Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years. Prior or current bleeding diathesis. Prior pelvic or prostate radiotherapy. Previous history of (or planned) androgen deprivation therapy. Evidence of metastatic disease. Any serious active disease or co-morbid medical condition, 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>IGRT* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions | Radiation: Image guided external beam radiotherapy with or without brachytherapy boost<br>* image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost<br>|
| Active Comparator: Arm 2<br>IGRT 37.5 Gy in 15 fractions + HDR brachytherapy boost 15 Gy | Radiation: Image guided external beam radiotherapy with or without brachytherapy boost<br>* image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost<br>Radiation: Brachytherapy<br>* Brachytherapy boost<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Ability to Accrue Patients | The ability to accrue 60 patients over an 18 month period to a study that randomizes men with intermediate-risk prostate cancer to curative intent treatment with image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost within a Canadian multicentre setting. | 21 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reported Adverse Events | Acute genitourinary (GU) and gastrointestinal (GI) adverse events. | 21 months | 
| Treatment Compliance | Treatment compliance will be monitored on an ongoing basis by Central Office and the designated radiotherapy quality assurance reviewer and will be described for both arms. | 21 months | 
| Radiotherapy Quality Assurance -Timing | The time from the the time from IGRT Real Time Review Signed to IGRT Real Time Review Uploaded. | 5 months |