Know Cancer

or
forgot password

A Phase II Randomized Control Trial of Conventional Versus Hypofractionated Radiation Regimen in Single Phase Using IMRT Technique and Long Term Androgen Suppression Therapy in High-risk Prostate Cancer Patients.


Phase 2
18 Years
N/A
Open (Enrolling)
Male
High-risk Prostate Cancer

Thank you

Trial Information

A Phase II Randomized Control Trial of Conventional Versus Hypofractionated Radiation Regimen in Single Phase Using IMRT Technique and Long Term Androgen Suppression Therapy in High-risk Prostate Cancer Patients.


Inclusion Criteria:



- Patient is 18 years of age or older

- Patient has histologically proven adenocarcinoma of prostate gland by needle core
samples or TURP with assigned Gleason score. Prostate biopsy performed within 180
days of enrollment (date of consent).

- Patient has high-risk prostate cancer (stage T3 or T4) and/or PSA greater than or
equal to 20 ng/ml and/or Gleason score 8 to 10

- No clinical or radiological evidence of nodal or distant metastasis(es).

- In the opinion of the treating oncologist, patient is fit to undergo radical external
beam radiotherapy to the prostate. Patients are accessible for treatment and follow
up.

- Patient does not have history of inflammatory bowel disease, anal stenosis,
colorectal surgery, or repeated endoscopic examinations/interventions related to
anorectal diseases.

- No history of prostatectomy, transurethral resection of prostate on more than one
occasion or previous pelvic radiotherapy.

- No history of androgen suppression for greater than or equal to 6 months and patient
is willing for androgen suppression treatment as per standard or at physician's
discretion.

- No previous malignancy within last five years except BCC or SCC skin or highly
curable malignancy where a prognosis for cure is > 80%.

- Patient signed informed consent.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The rate of late rectal toxicities between hypofractionated versus conventional fractionated schedules in high risk prostate cancer patients

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Nadeem Pervez

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cross Cancer Institute

Authority:

Canada: Health Canada

Study ID:

Pervez 11/30/2011 25859

NCT ID:

NCT01488968

Start Date:

March 2012

Completion Date:

December 2021

Related Keywords:

  • High-risk Prostate Cancer
  • high risk prostate cancer
  • hypofractionated radiation treatment
  • higher biological doses
  • acceptable rectal toxicity
  • Radiation Treatment
  • Prostatic Neoplasms

Name

Location