Dose Escalation Study of Preoperative SBRT for High Risk Prostate Cancer



Status:Active, not recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/6/2019
Start Date:October 7, 2015
End Date:December 31, 2020

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

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.


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
We found this trial at
1
site
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: Peter Johnstone, M.D.
Phone: 813-745-2169
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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mi
from
Tampa, FL
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