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A Pilot Study of Pre-Operative Conformal Radiotherapy in Patients With Radical Prostatectomy


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Male
Prostatic Neoplasm

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Trial Information

A Pilot Study of Pre-Operative Conformal Radiotherapy in Patients With Radical Prostatectomy

Inclusion Criteria


- Histologically confirmed carcinoma of the prostate

- High risk localized disease defined as clinical T1 or T2 plus [ (i) Gleason ¡Ý7,
PSA>10 ng/ml and <35 ng/ml OR (ii) PSA >15 ng/ml and less <35 ng/ml (any Gleason) ]

- No evidence of pelvic lymph node metastases on CT scan within 4 months of surgery

- No evidence of distant metastases on bone scan within 4 months of surgery

- No contraindication to pelvic radiation therapy

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To document the feasibility of pre-operative conformal radiation therapy in patients undergoing radical prostatectomy for localized prostate cancer who are at high risk for having local extra-prostatic disease at time of surgery.

Principal Investigator

Padraig Warde, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

Canada: Ethics Review Committee

Study ID:

UHN REB 01-0483-C

NCT ID:

NCT00252447

Start Date:

May 2000

Completion Date:

March 2009

Related Keywords:

  • Prostatic Neoplasm
  • Neoplasms
  • Prostatic Neoplasms

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