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

NCT ID: NCT01982786

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-22
• Study Completion Date: 2018-10-19

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Arm 1

IGRT\* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions

Group Type: ACTIVE_COMPARATOR

Image guided external beam radiotherapy with or without brachytherapy boost

Intervention Type: RADIATION

image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost

Arm 2

IGRT 37.5 Gy in 15 fractions

+ HDR brachytherapy boost 15 Gy

Group Type: ACTIVE_COMPARATOR

Image guided external beam radiotherapy with or without brachytherapy boost

Intervention Type: RADIATION

image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost

Brachytherapy

Intervention Type: RADIATION

Brachytherapy boost

Interventions

Image guided external beam radiotherapy with or without brachytherapy boost

image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost

Intervention Type: RADIATION

Brachytherapy

Brachytherapy boost

Intervention Type: RADIATION

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Canadian Cancer Trials Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Vigneault

Role: STUDY_CHAIR

CHUQ - Hotel Dieu de Quebec, Quebec QC

Douglas Loblaw

Role: STUDY_CHAIR

Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto On

Locations

Dr. H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, Canada

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

Lakeridge Health Oshawa

Oshawa, Ontario, Canada

Odette Cancer Centre

Toronto, Ontario, Canada

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

Windsor Regional Cancer Centre

Windsor, Ontario, Canada

CHUM - Hopital Notre-Dame

Montreal, Quebec, Canada

McGill University - Dept. Oncology

Montreal, Quebec, Canada

CHUQ-Pavillon Hotel-Dieu de Quebec

Québec, Quebec, Canada

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 29903505 (View on PubMed)

Other Identifiers

PR15

Identifier Type: -

Identifier Source: org_study_id