Preop Conformal Radiotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-05-31

Study Completion Date

2009-03-31

Brief Summary

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Radical prostatectomy and radical radiation therapy remain the standard treatment approaches for patients with clinically localized prostate cancer (T1, T2).Radical prostatectomy is most effective when the disease is organ confined at the time of surgery. However, in many series up to 60% of patients have positive resection margins at the time of surgery and there is evidence to suggest that these patients may not be curable by surgery alone. A number of preoperative clinical variables including clinical stage, serum Prostate Specific Antigen (PSA) and Gleason scorea re helpful in determining the probability of finding organ confined disease at the time of syrgery.

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Detailed Description

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Conditions

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Prostatic Neoplasm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pre-Operative Conformal Radiotherapy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No