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Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate | Clinical Trials | Clareo Health

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Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate

Phase II Study of Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate for Treatment of Localized, Non-Metastatic, High Risk Prostate Cancer

NCT01508390•Boston Medical Center

View on ClinicalTrials.gov

Summary

In this study, participants will have standard Androgen Deprivation Therapy and undergo standard external beam radiation therapy to the prostate and at-risk lymph nodes by Intensity Modulated Radiation Therapy. The subsequent \*boost\* radiation therapy to the prostate alone will be given using the CyberKnife, rather than using the standard Intensity Modulated Radiation Therapy. This study will also see how CyberKnife affects the quality of the participant's life.

Detailed Description

In this study, participants will have standard androgen deprivation therapy and undergo standard radiation therapy to the prostate and at-risk lymph nodes by intensity-modulated radiation therapy (IMRT). The subsequent \*boost\* radiation therapy to the prostate alone will be given using the CyberKnife, rather than using the standard Intensity Modulated Radiation Therapy. This study will also see how CyberKnife affects the quality of the participant's life.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Histologically proven adenocarcinoma of the prostate
•1. Gleason score (2-10)
•2. Biopsy within six months of date of registration
•3. Patient age \>18 years
•2. Clinical stage (American Joint Committee on Cancer 7th Edition)
•a. T-stage determined by physical exam (Digital Rectal Exam Required)
•i. MRI findings (e.g. extracapsular extension) can be used to determine T-staging
•b. N-stage determined using abdominopelvic CT scan and/or MRI
•c. M-stage determined by physical exam, CT and/or MRI, and bone scan (must be M0, excepting Lymph nodes)
•Please note: a SPECT bone scan including a CT of the abdomen and pelvis or an F18 Fluciclovine PET/CT fulfills protocol criteria for both the abdominopelvic CT and bone scan.
+16 more criteria

Exclusion Criteria

•1. No prior prostate surgery (including TURP) or prostate cancer treatment with the exception of androgen deprivation therapy
•2. No prior radiotherapy to the pelvis
•3. No implanted hardware (including metal) or other material that would prohibit appropriate treatment planning or treatment delivery
•4. No metastatic disease, with the exception of lymph node positive disease
•5. No chemotherapy for a malignancy in the last 5 years.
•6. No history of an invasive malignancy (other than basal or squamous skin cancers) in the last 5 years.
•7. No heart pacemaker, No metallic foreign body (metal sliver) in the eye, No aneurysm clip in the brain
•8. No history of a pelvic or horseshoe kidney
•9. No diagnosis of inflammatory bowel disease

Locations (1)

Boston Medical Center

Boston, Massachusetts, United States

Key Dates

Start Date

June 1, 2011

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2027

Last Updated

June 26, 2025

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

CyberKnife Boost

RADIATION

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

NCT05691465

Metastatic Prostate Adenocarcinoma With Neuroendocrine DifferentiationMetastatic Prostate Neuroendocrine Carcinoma+2 more

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RECRUITINGPHASE2

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC