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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of grade 3+ rectal toxicity

Outcome Description:

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

Outcome Time Frame:

Acute period (<3 months)

Safety Issue:

Yes

Principal Investigator

Andrew Loblaw, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sunnybrook Health Sciences Centre

Authority:

Canada: Health Canada

Study ID:

042-2010

NCT ID:

NCT01146340

Start Date:

May 2010

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms
  • Radiotherapy
  • Hypofractionation
  • Low and Intermediate Risk Prostate Cancer
  • Prostatic Neoplasms

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