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

Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days.

SBRT Prostate

William R Lee, MD

The purpose of this study is to evaluate the incidence of urinary and gastrointestinal acute and late side effects in patients treated with stereotactic body radiotherapy (SBRT) to the prostate. Stereotactic radiation therapy is given as five treatments over a 2-3 week period. The prostate is localized and the plan is reoptimized as needed prior to each treatment.

This protocol requires radiation treatments to be performed with a stereotactic technique with the use of a 3-D coordinate system defined by implanted transponders (i.e. Calypso) or use of the ExacTrac system and/or use cone-beam CT (CBCT) with fiducial markers.

Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer

A Phase II Study of Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer Using Continuous Real-time Evaluation of Prostate Motion and IMRT Plan Reoptimization Based on the Anatomy of the Day

Genitourinary Acute Toxicity is defined as Grade 3 or higher occurring within 90 days from the end of radiation treatment

Genitourinary Late Toxicity is defined as Grade 3 or higher occurring \>90 days from the end of radiation treatment

Gastrointestinal Acute Toxicity is defined as Grade 3 or higher occurring within 90 days of the end of radiation treatment

Gastrointestinal Late Toxicity is defined as Grade 3 or higher occurring \> 90 days from the end of radiation treatment

The EPIC-26 Short Form is a 13-item questionnaire. Scores range from 0-100, with higher scores representing better quality of life.

Duke University

Only Genitourinary and Gastrointestinal adverse events were reported.

Five fractions of 7.4 Gy each

SBRT Prostate: Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days.

Stereotactic Radiotherapy

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Joan Cahill, BSN RN OCN CCRP

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

Number of Participants With Genitourinary Acute Toxicity

Number of Participants With Genitourinary Late Toxicity

Number of Participants With Gastrointestinal Acute Toxicity

Number of Participants With Gastrointestinal Late Toxicity

Disease Free Survival

Urinary Domain

Sexual Domain

Bowel Domain

Hormonal Domain

Only participants who provided responses for each domain were analyzed.

Quality of Life, as Measured by the Expanded Prostate Cancer Index Composite (EPIC-26) Short Form

Overall Study

Dusten Macdonald, MD

This prospective study evaluates the clinical utility of a novel real-time localization system allowing for smaller volumes of normal tissue to be included in radiation field and determines dosimetric parameters and adverse effect profiles of radiation therapy using this technology. Subjects will have beacon transponders implanted into the prostate to more precisely localize the position of the organ during radiation therapy. Hypothesis: 1. Treatment with highly targeted radiation therapy can be delivered in a daily treatment time consistent with routine clinical practice. 2. Highly targeted radiation therapy with reduced PTV margin will result in a significant decrease in rectal and bladder volume treated.

This study will seek to establish the clinical feasibility of a novel real-time localization and tracking system for use of reduced PTV margins during intensity modulated radiation therapy (IMRT), which will allow treatment of smaller volumes of normal tissue during radiation therapy. Such a reduction in the PTV margins and the exposure of healthy tissue during treatment may allow for several future improvements in prostate radiotherapy including:

* decreased acute and chronic adverse effects with similar local tumor control
* dose escalation to achieve higher cure rates with similar adverse effects to standard dose treatment
* hypofractionation to shorten the time of, and lower the expense of, treatment without increased adverse effects.

Reduced Planning Target Volume (PTV) Margins for the Treatment of Prostate Cancer Using the Calypso 4D Localization System

Reduced PTV Margins for the Treatment of Prostate Cancer With IMRT Using Real-Time, State-of-the-Art Motion Tracking With the Calypso 4D Localization System: A Feasibility Study

During each radiation treatment fraction, therapists will record set up time, treatment time, total time and number of treatment interventions (repositioning/pausing) as well as the duration of the intervention caused by organ/target motion beyond planning target volume (PTV) margin using real time localization and tracking.

Standard methods vs. reduced planning target volume expansions will be analyzed:

1. Dose Volume Histogram (DVH), bladder and rectum
2. Volume receiving 77.4Gy by the prescription dose (V77.4Gy), V70Gy, and V50Gy of bladder and rectum

toxicity is based on the RTOG/NCI CTC and EPIC quality of life survey.

The Geneva Foundation

U.S. Army Medical Research Acquisition Activity

MD, MC

This prospective study at MAMC evaluates the utility of a rigid pelvic external immobilization compared to limited immobilization using a novel real-time localization system of the prostate. The sample population will include patients referred to the radiation oncology services of both facilities for definitive treatment of prostate cancer. The study will enroll 20 subjects from MAMC and evaluate data on 860 radiation therapy fractions.

Subjects will have Beacon® Transponders implanted into the prostate to more precisely localize the position of the organ during radiation therapy. They will be randomized to rigid pelvic immobilization using a Vac-Lok® system or limited immobilization with a band around the patient's feet. They will then undergo radiation therapy planning with standard planning target margins. The Calypso® 4D Localization System will monitor, in real time, the position of the prostate target and adjust radiation treatments as required to ensure accurate treatment of the prostate gland. The time of, the number, and extent of adjustments will be recorded for analysis.

Hypothesis: 1. When treating only the prostate, treatment with rigid pelvic immobilization is not necessary when using real-time, state-of-the-art motion tracking of the prostate.

Medical application: This study will seek to determine the utility of rigid external pelvic immobilization in patients who are set up using real-time, state-of-the-art motion tracking of the prostate. External immobilization devices have been criticized for being expensive, uncomfortable, time-consuming to make, occupying a lot of space in the treatment area, creating difficulties at the time of CT simulation, challenging for obese patients and obscuring skin marks that can help confirm patient set up. Omitting these devices (if found to be unnecessary) would potentially decrease treatment costs, improve patient comfort during treatment, and reduce overall treatment time. In high risk patients, gaining a better understanding of lymph node positioning relative to Calypso immobilization may allow for decreased PTV margins and therefore decreased normal tissue irradiated during radiation therapy.

Objective(s) of the investigation: This study will look at the efficacy of external pelvic immobilization in definitive radiation therapy of prostate cancer using a unique organ tracking system.

A. Primary Objective: To determine if rigid external pelvic immobilization demonstrates a reduction in positioning errors. This will be assessed by determining the median, mean and range of shifts performed in all 3 dimensions as part of initial isocenter set-up and during treatment using the Calypso system.

B. Secondary Objectives: The study will determine the simulation time, set up time, treatment time, total time and number of treatment interventions (repositioning/pausing) caused by organ/target motion beyond planning target volume (PTV) margin using real time localization. In the subset of high-risk patients, this study will assess positioning of the lymph node target using the combination of rigid external pelvic immobilization and the Calypso system.

External Immobilization Compared to Limited Immobilization Using a Novel Real-time Localization System of the Prostate

This will be assessed by determining the median, mean and range of shifts performed in all 3 dimensions as part of initial isocenter set-up and during treatment using the Calypso system.

During each radiation treatment fraction, therapists will record these timepoints and number/duaration of treatment inverventions.

This will be analyzed in the subset of high-risk patients.

Spots Global Cancer Trial Database for calypso

Every month we try and update this database with for calypso cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer	NCT00941915	Prostate Cancer	SBRT Prostate	40 Years - 82 Years	Duke University
Reduced Planning Target Volume (PTV) Margins for the Treatment of Prostate Cancer Using the Calypso 4D Localization System	NCT01589939	Prostate Cancer		40 Years -	U.S. Army Medical Research Acquisition Activity
Reduced Planning Target Volume (PTV) Margins for the Treatment of Prostate Cancer Using the Calypso 4D Localization System	NCT01589939	Prostate Cancer		40 Years -	U.S. Army Medical Research Acquisition Activity
External Immobilization Compared to Limited Immobilization Using a Novel Real-time Localization System of the Prostate	NCT01588938	Prostate Cancer		40 Years -	U.S. Army Medical Research Acquisition Activity
External Immobilization Compared to Limited Immobilization Using a Novel Real-time Localization System of the Prostate	NCT01588938	Prostate Cancer		40 Years -	U.S. Army Medical Research Acquisition Activity
External Immobilization Compared to Limited Immobilization Using a Novel Real-time Localization System of the Prostate	NCT01588938	Prostate Cancer		40 Years -	U.S. Army Medical Research Acquisition Activity

Spots Global Cancer Trial Database for calypso

Every month we try and update this database with for calypso cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for calypso cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.