Single Arm Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer

H. Lee Moffitt Cancer Center and Research Institute

Status

Withdrawn

Conditions

Prostate Cancer

Treatments

Device: Stereotactic Body Radiation Therapy (SBRT)

Study type

Interventional

Funder types

Other

Identifiers

NCT03748719

MCC-19670

Details and patient eligibility

About

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.

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.