Clinical trial NCT01982786: Feasibility Trial Of Image Guided External Beam Radiotherapy With Or Without High Dose Rate Brachytherapy Boost In Men With Intermediate-Risk Prostate Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Canadian Cancer Trials Group
Sponsor class: NETWORK
First posted: 2013-11-13
Enrollment: 57
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Feasibility of Ability to Accrue Patients
timeFrame: 21 months
Secondary outcomes:
measure: Number of Participants Reported Adverse Events
timeFrame: 21 months
measure: Treatment Compliance
timeFrame: 21 months
measure: Radiotherapy Quality Assurance -Timing
timeFrame: 5 months
Other outcomes:
Locations:
city: St. John's
country: Canada
facility: Dr. H. Bliss Murphy Cancer Centre
state: Newfoundland and Labrador
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health Oshawa
state: Ontario
city: Toronto
country: Canada
facility: Odette Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Univ. Health Network-Princess Margaret Hospital
state: Ontario
city: Windsor
country: Canada
facility: Windsor Regional Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: CHUM - Hopital Notre-Dame
state: Quebec
city: Montreal
country: Canada
facility: McGill University - Dept. Oncology
state: Quebec
city: Quebec City
country: Canada
facility: CHUQ-Pavillon Hotel-Dieu de Quebec
state: Quebec
Study officials:
affiliation: CHUQ - Hotel Dieu de Quebec, Quebec QC
name: Eric Vigneault
role: STUDY_CHAIR
affiliation: Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto On
name: Douglas Loblaw
role: STUDY_CHAIR
References:
citation: Vigneault E, Morton G, Parulekar WR, Niazi TM, Springer CW, Barkati M, Chung P, Koll W, Kamran A, Monreal M, Ding K, Loblaw A. Randomised 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 (CCTG PR15/ NCT01982786). Clin Oncol (R Coll Radiol). 2018 Sep;30(9):527-533. doi: 10.1016/j.clon.2018.05.007. Epub 2018 Jun 11.