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

S

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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