Single Arm Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/5/2019 |
| Start Date: | November 19, 2018 |
| End Date: | November 2022 |
A Single Arm Phase II Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer
This study involves Stereotactic Body Radiation Therapy (SBRT) followed by prostatectomy
(removal of the prostate). SBRT is a relatively new radiation technique in which a few doses
of radiation are delivered to small, well-defined tumors. It has been used effectively in
other cancers like lung and liver. The radiation will be given for only 5 days.
The purpose of this study is to compare the effects, good and/or bad, of different doses of
SBRT given before prostatectomy.
(removal of the prostate). SBRT is a relatively new radiation technique in which a few doses
of radiation are delivered to small, well-defined tumors. It has been used effectively in
other cancers like lung and liver. The radiation will be given for only 5 days.
The purpose of this study is to compare the effects, good and/or bad, of different doses of
SBRT given before prostatectomy.
- Histologically proven prostate adenocarcinoma.
- Clinical stage ≤T3a based on digital rectal exam (DRE) and ≤T3a based on MRI (within 3
months); N0-Nx; M0-Mx, or Gleason score 4 + 4.
- PSA ≤ 50 ng/ml, obtained within 3 months
- Prostate volume: ≤60 cc.
- IPSS score ≤15.
- No previous radiotherapy to the prostate or lower pelvis.
- Lymph node risk of <20% using https://www.mskcc.org/nomograms/prostate/pre_op.
- No prior radical prostatectomy or cryotherapy of the prostate (prior transurethral
resection or laser ablation are permitted).
- 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 3 years.
- No androgen deprivation therapy (ADT) can be prescribed prior to or during radiation
therapy.
- Participant must be able to have gold fiducial markers placed in the prostate. Note:
patients can be enrolled after fiducial markers have been placed, as long as the
procedure was done in accordance with the protocol (Section 4.2.2).
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Ability to understand and the willingness to sign a written informed consent document.
- Willing to fill out quality of life questionnaires.
We found this trial at
1
site
12902 USF Magnolia Dr
Tampa, Florida 33612
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: Peter Johnstone, MD
Phone: 813-745-2169
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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