High-Dose Lymph Node Intensity Modulated Radiation Therapy and Hypofractionated Prostate (SIB)

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-23

Study Completion Date

2030-06-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to find out the effects (good and bad) of using newer technologies that allow very precise delivery of radiation. These newer technologies are Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intensity Modulated Radiation Therapy (IMRT) Radiotherapy for Treating Prostate Pelvic Nodes

NCT00214136

Prostate Cancer

COMPLETED PHASE2

Phase I/II Hypofractionated Radiotherapy for Prostate Cancer

NCT00214097

Prostate Cancer

COMPLETED PHASE1/PHASE2

Mild Hypofractionation With Proton Therapy or IMRT for Intermediate-Risk Prostate Cancer

NCT01352429

Prostate Adenocarcinoma

ACTIVE_NOT_RECRUITING

Intensity Modulated Radiation Therapy for Prostate Cancer

NCT00214422

Prostate Cancer

COMPLETED EARLY_PHASE1

Intensity Modulated Radiation Therapy (IMRT) Pelvic Nodes Prostate

NCT00915122

Adenocarcinoma of the Prostate

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this study the treating physicians will deliver a high dose of radiation to pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy). The study will evaluate the response of the cancer and side effects of radiation to pelvic lymph nodes and to the prostate.

It is hoped that these newer technologies will:

1. allow a higher daily dose of radiation to the tumor and pelvic nodes
2. avoid nearby normal tissue and organs like the rectum and bladder
3. prevent the cancer from spreading or coming back

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IMRT & IGRT Radiation Therapy

In this study we will deliver a high dose of radiation to the pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy).

Group Type EXPERIMENTAL

Radiation Therapy

Intervention Type RADIATION

A high dose of radiation to the pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Radiation Therapy

A high dose of radiation to the pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy).

Intervention Type RADIATION

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT).

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histologically confirmed, adenocarcinoma of the prostate
* T1-2N0M0 with risk of pelvic lymph nodes involvement \>25% by Roach formula \[(2/3xPSA) + (Gleason Score - 6)x10\], or any T3-4N0M0
* Karnofsky Performance Scale \> 70.
* Prostate tumor biopsy grading by Gleason score classification is mandatory prior to registration.
* No prior pelvic or prostate radiation or chemotherapy for any reason; induction hormonal therapy prior to registration is acceptable.
* Patients must sign a study-specific consent form prior to registration.
* No evidence of distant metastases (Bone scanning)

Exclusion Criteria

* Clinical or pathological evidence of distant metastases (M1).
* Radical surgery for carcinoma of the prostate
* History of prior chemotherapy
* History of prior pelvic radiation therapy
* Children (age \< 18).

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No