Hypofractionated Image Guided Proton Therapy for Low andIntermediate Risk Prostate Cancer

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

RECRUITING

Clinical Phase

NA

Total Enrollment

235 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2025-12-31

Brief Summary

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

This study is being proposed to evaluate the use of moderate hypofractionated proton therapy in low and intermediate risk prostate cancer patients. Quality of life outcomes as well as gastrointestinal and genitourinary early and late toxicities will be analyzed and compared to conventional proton therapy regimens. It is thought that this regimen will produce comparable findings and would result in substantial health care cost savings, as well as, be more convenient for patients.

Related Clinical Trials

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

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

NCT01352429

Prostate Adenocarcinoma

ACTIVE_NOT_RECRUITING

Hypofractionation Proton Beam Therapy With Concurrent Treatment of Prostate and Pelvic Nodes for Prostate Cancer

NCT02874014

Prostate Cancer

COMPLETED PHASE2

Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer

NCT01492972

Prostate Cancer

RECRUITING PHASE3

Hypofractionated Proton Beam Therapy for Localized Prostate Cancer

NCT01950351

Stage I Prostate Adenocarcinoma AJCC v7 Stage II Prostate Adenocarcinoma AJCC v7

ACTIVE_NOT_RECRUITING PHASE1/PHASE2

Reduction of Gastrointestinal Toxicity in Prostate Cancer by Proton Spot Placement

NCT06200259

Prostate Cancer Prostate Adenocarcinoma Prostate Carcinoma

RECRUITING NA

Detailed Description

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

Patients will receive: 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks

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

NON_RANDOMIZED

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.

Low Risk Prostate Cancer

Hypofractionated Proton Therapy 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks

Group Type ACTIVE_COMPARATOR

Hypofractionated Proton Therapy

Intervention Type RADIATION

Intermediate Risk Prostate Cancer

Hypofractionated Proton Therapy 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks

Group Type ACTIVE_COMPARATOR

Hypofractionated Proton Therapy

Intervention Type RADIATION

Interventions

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

Hypofractionated Proton Therapy

Intervention Type RADIATION

Other Intervention Names

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

Proton Therapy

Eligibility Criteria

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

Inclusion Criteria

* Pathological (histologically) proven diagnosis of prostatic adenocarcinoma within 365 days (1 year) prior to study registration.

* History and physical exam with digital rectal exam of the prostate to establish clinical staging
* Clinical stage T1-T2c (AJCC 7th edition) within 90 days of registration.
* Prostate specific antigen (PSA) \< 20 ng/mL within 90 days prior to registration.
* Gleason Score \< 7.
* Eastern Cooperative Oncology Group(ECOG) Performance status 0-1.
* Clinically negative lymph nodes evaluated by imaging (pelvic +/- abdominal CT or MRI scan).
* Patients with lymph nodes equivocal or questionable by imaging are eligible without biopsy if the nodes are ≤ 1.5 cm in diameter; any node larger than this on imaging will require negative biopsy for eligibility, unless the node is know to be enlarged from prior scans and considered stable, per discretion of the treating physician.
* Patients must be 18 years of age or older.
* Patient must be able to provide study-specific informed consent prior to study entry.
* Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC) Questionnaire.
* No evidence of bone metastases (M0) on bone scan within 60 days prior to registration.
* Bone scan is not required for patients enrolled with a single intermediate risk factor only, but this scan may be obtained at the discretion of the treating physician. Patients with 2 or 3 risk factors will require a negative bone scan for eligibility.
* Equivocal bone scan findings are allowed if plain film x-rays are negative for metastasis.
* Patient is able to start proton therapy or neo-adjuvant hormonal therapy, when recommended, within 12 weeks of registration.
* No prior radiotherapy to the pelvic area.
* No prior prostate cancer therapy such as: prostatectomy, cryotherapy, chemotherapy or hyperthermia.
* Platelets ≥ 100,000 cells/mm3, Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3, Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.)
* Obs.: Patients with high risk factors, such as T3, Gleason 8-10 or PSA \> 20ng/mL who are not considered candidates for pelvic lymph node radiation treatment are still considered eligible for this study.

Exclusion Criteria

* • Prior radiotherapy to the pelvic area.

* Prior prostate cancer therapy such as: prostatectomy, cryotherapy, or hyperthermia.
* Prior systemic therapy (chemotherapy) for prostate cancer.
* Evidence of distant metastases.
* Regional lymph node involvement.
* Previous or concurrent cytotoxic chemotherapy for prostate cancer.
* Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition. Note however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immune-compromised patients.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No