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COMPLETEDPHASE1

Dose Escalation Study of Preoperative SBRT for High Risk Prostate Cancer

A Phase I Dose Escalation Study of Preoperative Stereotactic Body Radiation Therapy (SBRT) for High Risk Prostate Cancer

NCT02572284•H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given before prostatectomy. Depending when participants enter the study, they will be treated with either 5 or 6 gray (Gy) per day of radiation. A Gy is a measure of radiation dose. The standard dose is 10Gy per day when SBRT is the only treatment to the prostate and no surgery is planned. The researchers want to see which dose of radiation will work best with the least amount of side effects. About 4-6 weeks after SBRT, participants will have a prostatectomy.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Histologically-proven prostate adenocarcinoma.
•Clinical stage ≤T3a based on digital rectal exam and/or ≤T3a based on MRI (if done); N0-Nx; M0-Mx (AJCC 7th Edition)
•Prostate-specific antigen (PSA) ≤ 80 ng/ml, obtained within 3 months.
•Patients belonging in the National Comprehensive Cancer Network (NCCN) high recurrence risk group. High risk: Clinical stage T3a, or Gleason score = 8-10, or PSA \>20 ng/mL.
•Prostate volume: ≤ 80 cc on transrectal ultrasound
•IPSS score ≤15
•Zubrod performance status 0-2 or equivalent
•No prior total prostatectomy or cryotherapy of the prostate. Prior transurethral resection or laser ablation is permitted.
•No prior radiotherapy to the prostate or lower pelvis
•No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion
+7 more criteria

Exclusion Criteria

•Does not have a diagnosis of prostate adenocarcinoma
•Has very low risk, low risk, intermediate risk or very high risk disease as defined by the NCCN
•Has stage N1 or M1 (metastatic) disease
•Has a PSA of greater than 80 ng/ml obtained no greater than 3 months prior to randomization
•Prostate volume greater than 80 cc on transrectal ultrasound
•Zubrod performance status 3 or greater
•Prior total prostatectomy or cryotherapy of the prostate
•Prior radiation therapy to the pelvis
•Implanted hardware which limits treatment planning or delivery (determined by the investigator).
•Diagnosis of an invasive malignancy within 5 years (other than current prostate cancer or non-metastatic basal or squamous skin cancers)
+5 more criteria

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Key Dates

Start Date

January 27, 2016

Primary Completion Date

July 5, 2018

Completion Date

October 23, 2019

Last Updated

January 19, 2023

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

Stereotactic Body Radiation Therapy (SBRT)

RADIATION

Prostatectomy

PROCEDURE

Quality of Life Questionnaires

OTHER

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RECRUITINGPHASE2

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

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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: January 19, 2023Data 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.

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Dose Escalation Study of Preoperative SBRT for High Risk Prostate Cancer

Inclusion Criteria

Exclusion Criteria

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

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

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

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