Clinical trial NCT03748719: Single Arm Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer
Official title: A Single Arm Phase II Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostate Cancer
Keywords: High Risk Prostate Cancer
prostate
radiation therapy
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility 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.

Primary outcomes:
measure: Measure of PSA (Prostate Specific Antigen)
timeFrame: Up to 12 months
measure: Number of symptomatic adverse anastomotic events
timeFrame: Up to 12 months
Secondary outcomes:
measure: Mean Catheterization Time
timeFrame: Up to 4 weeks post surgery
measure: Mean Hospital Stay
timeFrame: Up to 2 week post surgery
measure: Quality of Life assessment
timeFrame: Baseline, at 2 weeks, 4 weeks, 2 months and every 3 months up to 12 months post surgery
Other outcomes:
Locations:
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Peter Johnstone, MD
role: PRINCIPAL_INVESTIGATOR
References: