Medical and Economic Evaluation for Intermediate-risk Prostate Cancer (GETUGP05)

Civil Hospices of Lyon

Status: Unknown

Conditions: Prostate Cancer

Treatments: Radiation: Exclusive external beam radiotherapy; Radiation: Brachytherapy boost with external beam radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02271659

2011-704

Details and patient eligibility

About

The aim of the present phase III study is two-folded: 1) to show a superiority of external beam radiotherapy combined with a brachytherapy boost versus exclusive external beam radiotherapy and 2) to evaluate the economic impact of each treatment.

The study includes 33 cancer centres, the inclusion time is of 2 years and the follow-up is of 5 years.

Enrollment: 298 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age between 18 and 80 years;
• life expectancy of greater than 10 years;
• prostate adenocarcinoma histologically proven;
• prostate cancer has to be of intermediate-risk based on at least one of the three following criteria: PSA between 10 ng/ml and 20 ng/ml, and/or a Gleason score of 7 and/or a T2B. Karnofsky performance status ≥ 60% and consequently performance status ECOG 0-2.
• the patient has to be the beneficiary of the social security system (order n° 2006-477 from April 26th 2006);
• the signed consent form.

Exclusion criteria

• PSA level > 20;
• Gleason > 7;
• clinical T3A or T3B or MRI (a simple suspicion/ doubt on the MRI regarding the T3A won't be an exclusion criterion);
• prostate volume > 60 cc;
• pelvic lymph nodes involvement at dissection or imaging (ADP > 1.5 cm);
• concurrent hormone therapy;
• the presence of distant metastasis (M1);
• history of abdominal or pelvic irradiation;
• history of prostate resection in the previous 6 months and/or not allowing the implantation of markers;
• history of uncontrolled cancer and/or treated since less than 5 years (excepting the basal-cell carcinoma);
• urinary discomfort with an IPSS (International Prostate Symptom Score) > 15 (without alpha-blocking);
• inflammatory bowel disorder such as ulcerative colitis or the Crohn's disease;
• other undergoing study that may interfere with the present study;
• patient under legal protection measure.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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298 participants in 2 patient groups

Brachytherapy boost

Experimental group

Description:

Brachytherapy boost with external beam radiotherapy. External beam radiotherapy of 46 Gy delivered to the prostate and the first centimeter of the seminal vesicles with a brachytherapy boost (of iodine-125 seeds (110Gy) or high dose rate (14Gy) with iridium-192) only to the prostate. Each center will choose the appropriate brachytherapy technique

Treatment:

Radiation: Brachytherapy boost with external beam radiotherapy

Exclusive external beam irradiation

Active Comparator group

Description:

Exclusive external beam radiotherapy. External beam radiotherapy of 46 Gy delivered to the prostate and the first centimeter of the seminal vesicles with an external beam radiotherapy of 80 Gy to the prostate alone.

Treatment:

Radiation: Exclusive external beam radiotherapy