Prostate Cancer Clinical Trial

Dose Escalation Study of Preoperative SBRT for High Risk Prostate Cancer

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.

View Eligibility Criteria

Eligibility Criteria

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
No history of an invasive malignancy (other than this prostate cancer, or non-metastatic basal or squamous skin cancers) in the last 5 years
No androgen deprivation therapy (ADT) can be prescribed prior to or during radiation therapy
Must be able to have gold fiducial markers placed in the prostate or, if patient already has fiducial markers placed, they must be in accordance with the protocol specifications
Ability to understand and the willingness to sign a written informed consent document
Willingness to fill out IPSS, SHIM, and EPIC quality of life forms
Age ≥18 years
IPSS (AUA) score ≤15

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)
The use of androgen deprivation therapy (ADT) prior to registration or during radiation
Inability to have gold fiducial markers placed in the prostate, or fiducial markers already placed, that are not in accordance with the protocol
Unwilling or inability to give informed consent
Not willing to fill out IPSS, SHIM, and EPIC quality of life questionnaires
IPSS score >15

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

7

Study ID:

NCT02572284

Recruitment Status:

Active, not recruiting

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

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There is 1 Location for this study

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H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

7

Study ID:

NCT02572284

Recruitment Status:

Active, not recruiting

Sponsor:


H. Lee Moffitt Cancer Center and Research Institute

How clear is this clinincal trial information?

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