Prostate Cancer
Conditions
Keywords
High Risk Prostate Cancer, prostate, radiation therapy
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.
Interventions
DEVICEStereotactic Body Radiation Therapy (SBRT)
SBRT treatment
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure of PSA (Prostate Specific Antigen) | Up to 12 months | Measure of PSA through treatment. PSA is expected to be undetectable (\<0.2 mg/ml) after prostatectomy and radiation therapy. |
| Number of symptomatic adverse anastomotic events | Up to 12 months | Number of symptomatic anastomotic events related to pre-operative SBRT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Catheterization Time | Up to 4 weeks post surgery | Average time of catheterization following prostatectomy |
| Mean Hospital Stay | Up to 2 week post surgery | Average time of hospitalization after prostatectomy |
| Quality of Life assessment | Baseline, at 2 weeks, 4 weeks, 2 months and every 3 months up to 12 months post surgery | Quality of Life will be assessed using 2 questionnaires: International Prostate Symptom Score (IPSS) and Sexual Health Inventory for Men (SHIM). The IPSS is an eight question questionnaire of symptoms ranging from 0 not at all to 5 always. The SHIM is a five question questionnaire ranging from 1 almost never or never to 5 almost always or always to determine erectile dysfunction. |
Outcome results
None listed