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Completed

NCT Number: NCT01146340

Safety and Efficacy Study of Dose-escalated Hypofractionated Radiotherapy For Prostate Cancer

The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (40 Gy / 5 fractions / 29 days) for the treatment of low- and intermediate-risk prostate cancer.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men >18 years
  • Histologically confirmed prostate adenocarcinoma
  • Low or low-intermediate risk prostate cancer, defined as Clinical stage T1-2b, Gleason Score <=6, and PSA <15 ng/mL, OR Clinical stage T1-2b, Gleason Score 7, and PSA <=10 ng/mL

Exclusion criteria

  • Prior pelvic radiotherapy
  • Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
  • Diagnosis of bleeding diathesis
  • Presence of a hip prosthesis
  • Pelvic girth >40cm - Large prostate (>90cm3) on imaging
  • Severe lower urinary tract symptoms (International Prostate Symptom Score >19 or nocturia >3)

Treatment and study plan

Hypofractionated radiotherapy

Radiation

40 Gy / 5 fractions / 29 days

Primary outcomes

  1. Incidence of grade 3+ rectal toxicity

    Time frame: Acute period (<3 months)

    Common Terminology Criteria for Adverse Events (CTCAE) v3.0

Secondary outcomes

  1. Incidence of grade 3+ urinary toxicity

    Time frame: Acute (<3 months) and Late (>6 months)

    Common Terminology Criteria for Adverse Events (CTCAE) v3.0

  2. Quality of Life

    Time frame: 5 years

    Expanded Prostate Cancer Index Composite (EPIC)

  3. Biochemical (ie. prostate specific antigen) disease free survival

    Time frame: 5 year

  4. Incidence of grade 3+ rectal toxicity

    Time frame: Late (>6 months)

    Common Terminology Criteria for Adverse Events (CTCAE) v3.0

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Canadian Association of Radiation Oncology

Registry information

Official study title

Phase I/II Study of Dose-Escalated Hypofractionated Radiotherapy for Low- and Intermediate-Risk Prostate Cancer

Acronym: PHART6

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Jun 17, 2010
Registry last updated
Oct 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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