Trial of Hypofractionated IMRT Boost Versus Conventional IMRT Boost for Localized High Risk Prostate Cancer (RCT-PHART2)

Sunnybrook Health Sciences Centre

Status: Active, not recruiting

Conditions: Prostate Cancer

Treatments: Radiation: Hypofractionated IMRT Radiation treatment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04239599

RCT- PHART2

Details and patient eligibility

About

Hypofractionation: 48 Gy in 25 fractions to pelvic lymph nodes while the prostate receives 68 Gy in 25 fractions concomitantly.

Standard Fractionation: pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy over 39 fractions.

Full description

Half the participants will receive using a one phase IMRT plan, the pelvic lymph nodes will be treated to a dose of 48 Gy in 25 fractions, while the prostate will be treated to a dose of 68 Gy in 25 fractions concomitantly (simulataneous integrated boost).

The other half of the participants will receive Standard fractionation using 2 sequential IMRT plans, the pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy.

Enrollment: 178 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent obtained.
• Histologically confirmed diagnosis of adenocarcinoma of the prostate.
• Clinical stage T1-2 N0 M0, Gleason Score ≤ 7, PSA 20 - 100
• T1-2 N0 M0, Gleason Score 8 - 10, PSA ≤ 100
• T3 N0 M0, any Gleason Score, PSA ≤ 100

Exclusion criteria

• Patients with unilateral or bilateral hip replacement.
• Patients with active collagen vascular disease.
• Patients with active inflammatory bowel disease.
• Patients with previous radiotherapy to the pelvis.
• Patients with ataxia telangiectasia.
• Patients with nodal or distant metastases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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178 participants in 2 patient groups

Hypofractionation

Experimental group

Description:

Hypofractionation: Using a one phase IMRT plan, the pelvic lymph nodes will be treated to a dose of 48 Gy in 25 fractions, while the prostate will be treated to a dose of 68 Gy in 25 fractions concomitantly (simulataneous integrated boost) + 18-36 months of Eligard Hormone injection.

Treatment:

Radiation: Hypofractionated IMRT Radiation treatment

Standard Fractination

Active Comparator group

Description:

Using 2 sequential IMRT plans, the pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy + 18-36 months of Eligard Hormone injection.

Treatment:

Radiation: Hypofractionated IMRT Radiation treatment