NCT00084552

Intensity-Modulated Radiation Therapy With or Without Decreased Radiation Dose to Erectile Tissue in Treating Patients With Stage II Prostate Cancer

Completed NA Results posted Last updated 25 February 2021

What this trial tests

NA trial testing radiation therapy in Prostate Cancer in 116 participants. Completed in 5 May 2016.

Timeline

11 December 2003

Primary endpoint
24 August 2013

5 May 2016

Quick facts

Lead sponsor	Fox Chase Cancer Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	116
Start date	11 December 2003
Primary completion	24 August 2013
Estimated completion	5 May 2016
Sites	1 location across United States

Drugs / interventions tested

• radiation therapy — full drug profile →

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →
• Sexual Dysfunction — all drugs for Sexual Dysfunction →
• Sexuality and Reproductive Issues — all drugs for Sexuality and Reproductive Issues →

Sponsor

Fox Chase Cancer Center — full company profile →

Who can join

18 and older, male only, with Prostate Cancer or Sexual Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Erectile Dysfunction Rates Primary · 5 year duration after completion of radiotherapy

Postage Stamp Test -A row of stamps is placed around the base of the penis and the ends are moistened and joined. If the circle is broken in the morning then the subject was recorded as having had a nocturnal erection International Index of Erectile Function (IIEF) Questionnaire * 15-item questionnaire that measures erectile function * Includes companion questionnaire which measures how the partner feels her sexual relationship with the patient has changed since his cancer diagnosis and therapy

Group	Value	95% CI
s-IMRT	27
ETS-IMRT	36

Percentage of Patients With Freedom From Biochemical Failure Secondary · 2 years after treatment

Patients without documented failure will undergo needle biopsy of the prostate. A minimum of 12 core biopsies will be taken and additional biopsies will be taken from any suspicious areas (ultrasound or palpation) and/or the original site of biopsy confirmation of prostate cancer at diagnosis. The 12 biopsy sites include sextant, bilateral lateral base, bilateral lateral mid-gland and bilateral transition zone. These data will enable us to evaluate the extent of disease eradication, as well as the prognostic significance of positive biopsies in otherwise palpably normal prostate glands after t

Group	Value	95% CI
s-IMRT	90.7
ETS-IMRT	91.8

Acute GI Toxicity Secondary · 5 years after treatment

Group	Value	95% CI
s-IMRT	1
ETS-IMRT	6

Acute GU Toxicity Secondary · 5 years after treatment

Group	Value	95% CI
s-IMRT	20
ETS-IMRT	27

Sponsor's own description

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in standard radiation therapy) may reduce damage to healthy tissue near the tumor. It is not yet known whether reducing the dose of radiation to erectile tissue will help prevent erectile dysfunction.

PURPOSE: This randomized phase III trial is studying intensity-modulated radiation therapy alone to see how well it works compared to intensity-modulated radiation therapy with reduced doses to erectile tissue in treating patients with stage II prostate cancer.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.