Clinical trial NCT02572284: Dose Escalation Study of Preoperative SBRT for High Risk Prostate Cancer
Official title: A Phase I Dose Escalation Study of Preoperative Stereotactic Body Radiation Therapy (SBRT) for High Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: Stereotactic Body Radiation Therapy (SBRT)
High Risk Prostate Cancer
Preoperative SBRT
Prostate Adenocarcinoma
Prostatectomy
Quality of Life
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2015-10-08
Enrollment: 7
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: The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given before prostatectomy. Depending when participants enter the study, they will be treated with either 5 or 6 gray (Gy) per day of radiation. A Gy is a measure of radiation dose. The standard dose is 10Gy per day when SBRT is the only treatment to the prostate and no surgery is planned. The researchers want to see which dose of radiation will work best with the least amount of side effects. About 4-6 weeks after SBRT, participants will have a prostatectomy.


Eligibility criteria: Inclusion Criteria:

* Histologically-proven prostate adenocarcinoma.
* Clinical stage ≤T3a based on digital rectal exam and/or ≤T3a based on MRI (if done); N0-Nx; M0-Mx (AJCC 7th Edition)
* Prostate-specific antigen (PSA) ≤ 80 ng/ml, obtained within 3 months.
* Patients belonging in the National Comprehensive Cancer Network (NCCN) high recurrence risk group. High risk: Clinical stage T3a, or Gleason score = 8-10, or PSA \>20 ng/mL.
* Prostate volume: ≤ 80 cc on transrectal ultrasound
* IPSS score ≤15
* Zubrod performance status 0-2 or equivalent
* No prior total prostatectomy or cryotherapy of the prostate. Prior transurethral resection or laser ablation is permitted.
* No prior radiotherapy to the prostate or lower pelvis
* 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 5 years
* No androgen deprivation therapy (ADT) can be prescribed prior to or during radiation therapy
* Must be able to have gold fiducial markers placed in the prostate or, if patient already has fiducial markers placed, they must be in accordance with the protocol specifications
* Ability to understand and the willingness to sign a written informed consent document
* Willingness to fill out IPSS, SHIM, and EPIC quality of life forms
* Age ≥18 years
* IPSS (AUA) score ≤15

Exclusion Criteria:

* Does not have a diagnosis of prostate adenocarcinoma
* Has very low risk, low risk, intermediate risk or very high risk disease as defined by the NCCN
* Has stage N1 or M1 (metastatic) disease
* Has a PSA of greater than 80 ng/ml obtained no greater than 3 months prior to randomization
* Prostate volume greater than 80 cc on transrectal ultrasound
* Zubrod performance status 3 or greater
* Prior total prostatectomy or cryotherapy of the prostate
* Prior radiation therapy to the pelvis
* Implanted hardware which limits treatment planning or delivery (determined by the investigator).
* Diagnosis of an invasive malignancy within 5 years (other than current prostate cancer or non-metastatic basal or squamous skin cancers)
* The use of androgen deprivation therapy (ADT) prior to registration or during radiation
* Inability to have gold fiducial markers placed in the prostate, or fiducial markers already placed, that are not in accordance with the protocol
* Unwilling or inability to give informed consent
* Not willing to fill out IPSS, SHIM, and EPIC quality of life questionnaires
* IPSS score \>15

Primary outcomes:
measure: Dose Limiting Toxicity
timeFrame: Up to 28 ± 5 days post-prostatectomy
Secondary outcomes:
measure: Occurrence of Late Toxicity
timeFrame: 90+ days after start of radiotherapy
measure: Mean Catheterization Time for Study Participants
timeFrame: Up to 18 months post surgery
measure: Mean Hospital Stay for Study Participants
timeFrame: Up to 18 months post surgery
measure: Reoperation Rate for Study Participants
timeFrame: Up to 18 months post surgery
measure: Patient-Assessed Changes in Health-Related Quality of Life (HRQOL) - Expanded Prostate Cancer Index Composite (EPIC)
timeFrame: Up to 18 months post surgery
measure: Patient-Assessed Changes in HRQOL - International Prostate Symptom Score (IPSS)
timeFrame: Up to 18 months post surgery
measure: Patient-Assessed Changes in HRQOL - Rectal Assessment Scale (RAS)
timeFrame: Up to 18 months post surgery
measure: Patient-Assessed Changes in HRQOL - Sexual Health Inventory for Men (SHIM)
timeFrame: Up to 18 months post surgery
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Peter Johnstone, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Julio Pow-Sang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: