Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Micronutrients

Anti-Infective Agents

Other Dietary Supplements

Benzocaine

Iodine

Cadexomer iodine

Tannic Acid

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.

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.

Intensity Modulated External Beam Radiation Therapy

William J Morris, MD

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).

Justification:

Patients with low risk and low-tier intermediate risk prostate cancer have a number of different standard treatment options to chose from that include a radical prostatectomy, conventional external beam radiotherapy (EBRT), or permanent interstitial prostate brachytherapy (PIPB). Each of these treatment options have good outcomes, although they are known to have a small risk of complications associated with each of them. Unfortunately, these treatment options have never been directly compared and therefore it is difficult to determine how these treatment options compare with respect to overall outcomes and toxicity.

A recent analysis from the BC Cancer Agency suggested that patients treated with conventional EBRT within the Agency had inferior outcomes compared to PIPB. This data, as well as other indirect evidence, suggest that conventional EBRT may be a suboptimal treatment option compared to PIPB. Intensity modulated external beam radiotherapy (IMRT) is a new technology that allows for the delivery of high doses of radiation that tightly conforms to the target and limits the dose to surrounding critical structures. Although IMRT is currently a standard therapeutic option that is utilized in other cancer sites at the BC Cancer Agency, it has not been utilized in prostate cancer yet. Recent evidence has confirmed that this experimental therapy is able to allow for the safe escalation of dose for prostate cancer patients, which may lead to improved outcomes, without increasing toxicity. There is no current evidence that side effects and complication risks associated with IMRT are associated with any serious risk of increased toxicity, although this continues to be studied.

This study will compare this new therapeutic approach (IMRT) directly with a standard treatment option for prostate cancer patients (PIPB). This trial will allow us to determine how the toxicities of these treatments compare with each other and, if successful, will potentially lead to a larger study which will analyse how the outcomes of these therapeutic interventions compare. We hope that this trial will make an important contribution to the care and future management of patients with prostate cancer.

Objectives:

Primary Objective:

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

Secondary Objectives:

This trial is also intended to determine:

* The willingness of eligible patients to be randomized to the treatment interventions.
* Obstacles to accrual that need to be addressed.
* Testing our ability to meet accrual targets.
* Checking quality assurance benchmarks for IMRT and PIPB procedures.
* Discovering and relieving bottlenecks in IMRT planning and procedures.
* Quality of life.
* Pathological local control.
* Biochemical relapse-free survival.
* Metastasis-free survival.
* Overall survival.

Research Method:

The patients will be randomly assigned with equal probability to one of two treatment arms:

Arm 1 (Control Arm) - Permanent interstitial prostate brachytherapy (PIPB). Arm 2 (Experimental Arm) - Intensity modulated external beam radiation therapy (IMRT).

Statistical Analysis:

Primary Endpoints:

Acute GI grade 3 or higher toxicity. Acute GU grade 3 or higher toxicity. Late GI grade 3 or higher toxicity. Late GU grade 3 or higher toxicity.

Secondary Endpoints:

All acute and late toxicities. Quality of life scores (Using the expanded prostate cancer index composite - EPIC).

Pathological local control. Biochemical relapse-free survival (using Phoenix definition). Metastasis-free survival. Overall survival.

Planned sample size: 50 patients in total (i.e. 25 patients in each treatment arm).

Statistical analysis:

The two groups will be compared with respect to their primary and secondary endpoints. Appropriate statistical analysis using a student t test for a statistical difference in crude rates of grade 3 or higher toxicity between the two treatment arms will be performed. All endpoints will be analysed for crude event rates with 95% confidence intervals for each group.

With a sample size of only 50 patients, this trial is not powered to detect differences in the incidence of common self-limited side effects and adverse reactions compared to standard therapy. For this reason, the trial's limited power is augmented by a Trial Safety Committee (TSC) which is bound by rules that require suspension/ termination of trial accrual in the event of major complications (See Section 8.3 of Data Monitoring - Human Ethics Application for Clinical Study or Part I: Section 5.3 on page 11 of the protocol).

Intensity Modulated Versus Interstitial - Radiation Therapy

A Randomized Phase II Study Comparing Intensity Modulated External Beam Radiation Therapy (IMRT) Versus Permanent Interstitial Prostate Brachytherapy (PIPB) for Low Risk and Low-tier Intermediate Risk Prostate Cancer

British Columbia Cancer Agency

Radiation Oncologist

Symptoms and General Pathology

Adenocarcinoma

Recurrence

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Androgens

Patients undergo hypofractionated intensity modulated radiotherapy once daily, 5 days a week, for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with intermediate- and high-risk disease may also receive concurrent and adjuvant or long-term androgen deprivation therapy for up to 36 months.

Low risk - 69.6 Gy in 2.4 Gy fractions to prostate

Intermediate risk - delivered in 30 fractions with neoadjuvant and concurrent androgen deprivation therapy: 72 Gy in 2.4 Gy fractions to prostate + 60 Gy in 2 Gy fractions to seminal vesicles +/- 50.4 Gy in 1.68 Gy fractions to lymph nodes

High risk - 30 fractions with neoadjuvant, concurrent, and long term adjuvant androgen deprivation therapy: 72 Gy in 2.4 Gy fractions to prostate + 60 Gy in 2 Gy fractions to seminal vesicles +/- 50.4 Gy at 1.68 Gy fractions to lymph nodes

intensity modulated external beam radiation therapy

Michael G. Chang, MD

RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Specialized radiation therapy, such as intensity-modulated radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This clinical trial studies intensity-modulated external beam radiation therapy in treating patients with prostate cancer.

PRIMARY OBJECTIVES:

I. To demonstrate that patients can safely receive IMRT teletherapy using the proposed IMRT fractionation schedule without experiencing a treatment limiting toxicity.

SECONDARY OBJECTIVES:

I. To assess treatment efficacy through the surrogate measures of PSA nadir and biochemical failure-free survival.

OUTLINE: Patients undergo hypofractionated intensity modulated radiotherapy once daily, 5 days a week, for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with intermediate- and high-risk disease may also receive concurrent and adjuvant or long-term androgen deprivation therapy for up to 36 months. After completion of study treatment, patients are followed at 4-6 weeks, every 4 months for 3 years, every 6 months for 2 years, and then annually until year 5.

Intensity-Modulated External Beam Radiation Therapy in Treating Patients With Prostate Cancer

Study of Hypofractionated Intensity Modulated External Beam Therapy for the Treatment of Patients With Adenocarcinoma of the Prostate

Virginia Commonwealth University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Intensity Modulated Versus Interstitial - Radiation Therapy	NCT00407875	Prostate Cancer	Intensity Modul...	-	British Columbia Cancer Agency
Intensity-Modulated External Beam Radiation Therapy in Treating Patients With Prostate Cancer	NCT01117935	Adenocarcinoma ... Stage I Prostat... Stage II Prosta... Stage III Prost... Stage IV Prosta...	intensity modul...	18 Years -	Virginia Commonwealth University

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