Intensity Modulated Versus Interstitial - Radiation Therapy

NCT00407875 | Unknown

• 1 other identifier: IMVI-RT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: The purpose of this trial is to compare two different treatment options for patients with low risk and low-tier intermediate risk prostate cancer. The two treatment arms being compared in this study are: (control arm) permanent interstitial prostate brachytherapy (PIPB) VERSUS (experimental arm) intensity modulated external beam radiation therapy (IMRT). Hypothesis: The acute and late toxicities experienced by patients in the experimental arm (IMRT) are not significantly worse then the toxicities experienced by patients in the control arm (PIPB).

Conditions

Prostate Cancer

Keywords

Prostate; Cancer; Radiation

Outcome Measures

Primary Outcomes (1)

• The primary end point of this study is the acute and late toxicities of the therapeutic interventions.

  Through study completion. Approximately 5 years.

Secondary Outcomes (9)

• The willingness of eligible patients to be randomized to the treatment interventions.

  1 year

• Obstacles to accrual that need to be addressed.

  1 year

• Testing our ability to meet accrual targets.

  1 year

• Checking quality assurance benchmarks for IMRT and PIPB procedures.

  1 year

• Quality of life based on urinary function, bowel habits, sexual function, and hormonal function

  Assessed at 6 weeks, 6, 9, 12, 18, 24 ,30, 36 months. Then annually until end of participation

Study Arms (2)

Permanent interstitial prostate brachytherapy (PIPB)

ACTIVE COMPARATOR

patient will undergo permanent interstitial prostate brachytherapy (PIPB) using a transperineal approach to deliver 125Iodine Rapidstrand® seeds at the facilities of the British Columbia Cancer Agency (BCCA) by one or more of the certified prostate brachytherapists in the BCCA Prostate Brachytherapy Program. The minimum peripheral dose (MPD) to the prostate gland of the implant will be 144 Gy as per TG 43 protocol. A modified peripheral loading technique will be utilized in an effort to maintain the periurethral dose to \< 150% of the MPD. Within 48 hours of the implant, the patient will undergo a day 0 CT scan of the pelvis to assess post implant dosimetry using the standard BCCA protocol.

Procedure: Intensity Modulated External Beam Radiation Therapy

Intensity modulated external beam radiation therapy (IMRT)

EXPERIMENTAL

patient will undergo a course of intensity modulated external beam radiation therapy (IMRT) to a volume encompassing the prostate gland. The total radiation dose will be 70 Gy delivered in 28 fractions, so that the minimum dose to the PTV is 70 Gy, with CT simulation used for planning the treatment. Prior to starting the course of IMRT, fiducial markers will be placed in the prostate to assist in localization of the prostate for planning and quality assurance during treatment.

Procedure: Intensity Modulated External Beam Radiation Therapy

Interventions

Intensity Modulated External Beam Radiation Therapy PROCEDURE

Intensity modulated external beam radiation therapy (IMRT); Permanent interstitial prostate brachytherapy (PIPB)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically proven adenocarcinoma of the prostate.
• Registration must occur within 20 weeks of biopsy.
• History and physical examination within 8 weeks prior to randomization.
• Patients must have either low risk or low-tier intermediate risk prostate cancer (Low risk must have all of: clinical stage \<= T2b, Gleason score \<= 6, and initial PSA \<= 10; Low-tier intermediate risk must have: clinical stage \<= T2c, \< 50% positive biopsy cores, AND EITHER Gleason score = 7 and initial PSA \<= 10 OR Gleason score \<= 6 and initial PSA \> 10 and \<= 15.)
• Patients must have a ECG, PSA, TTT, CBC, electrolytes, Cr, INR, PTT, and random glucose within 2 weeks of registration.
• Patients must be fit for general or spinal anesthetic.
• Patients must have an estimated life expectancy of at least 10 years.
• Patients must have an ECOG performance status of 0 - 2.
• Patients must have no contraindications for high dose pelvic irradiation or transperineal interstitial brachytherapy.
• Patients must not have received prior radiation therapy to the pelvis.
• Patients must have no history of inflammatory bowel disease.
• Patients must not have received prior hormonal therapy or chemotherapy.
• Patients must not have any hormonal therapy planned as part of the therapeutic intervention.
• Patients must have prostate volumes \< 60 cm3 on transrectal ultrasound.
• Patients must not have received prior surgical treatment for prostate cancer including TURP, TURB, cryotherapy, laser ablation or microwave therapy.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

BC Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• William J Morris, MD

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: December 1, 2006
• First Posted: December 5, 2006
• Study Start: March 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2020
• Last Updated: July 13, 2018

Record last verified: 2018-07

Locations

CA (1)