Status:
WITHDRAWN
Single Arm Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
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 d...
Eligibility Criteria
Inclusion
- 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. No more than 1 lymph node \>1 cm.
- 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 \<35% 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.
Exclusion
Key Trial Info
Start Date :
November 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03748719
Start Date
November 19 2018
End Date
December 4 2019
Last Update
May 22 2020
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