Dose Escalation Study of Preoperative SBRT for High Risk Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

A Phase I Dose Escalation Study of Preoperative Stereotactic Body Radiation Therapy (SBRT) for High Risk Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02572284
• Other study ID #: MCC-18201
• Status: Completed
• Phase: Phase 1
• Start date: January 27, 2016
• Est. completion date: October 23, 2019

Study information

• Verified date: January 2023
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: October 23, 2019
• Est. primary completion date: July 5, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Stereotactic Body Radiation Therapy (SBRT)
The first group of patients to enter the study will receive 5 Gy of SBRT per day for 5 days, the second group will receive 6 Gy per day for 5 days. Each treatment will take about 3 minutes and be given as an outpatient at Moffitt Cancer Center.

Procedure:
• Prostatectomy
About 4-6 weeks after SBRT, participants will have a prostatectomy.

Other:
• Quality of Life Questionnaires
Patient assessed health-related quality of life (HRQOL). Quality of Life (QOL) will be assessed using Prostate Symptom Score (IPSS), rectal assessment scale (RAS), sexual health inventory for men (SHIM), and Expanded Prostate Cancer Index Composite (EPIC) patient questionnaires: administered prior to SBRT, and at 2 weeks, 4 weeks, 2 months and then every 3 months up to 18 months post-prostatectomy.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicity	Acute dose-limiting toxicity and quality of life due to preoperative SBRT followed by robotic-assisted laparoscopic radical prostatectomy at 14 ± 5 days and 28 ± 5 days post-prostatectomy in high risk prostate cancer patients. In order to assess the toxicity of preoperative SBRT, the severity of specific events will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 form where a score of =3 is considered dose-limiting.	Up to 28 ± 5 days post-prostatectomy
Secondary	Occurrence of Late Toxicity	Late (defined as occurring more than 90 days after the start of radiotherapy) toxicity that is grade 2 or more as defined by the Common Terminology Criteria for Adverse Events version 4.	90+ days after start of radiotherapy
Secondary	Mean Catheterization Time for Study Participants	Mean catheterization time for study participants, compared to existing mean statistics for robotic-assisted laparoscopic radical prostatectomy.	Up to 18 months post surgery
Secondary	Mean Hospital Stay for Study Participants	Mean hospital stay for study participants, compared to existing mean statistics for robotic-assisted laparoscopic radical prostatectomy.	Up to 18 months post surgery
Secondary	Reoperation Rate for Study Participants	Mean reoperation rate for study participants, compared to existing mean statistics for robotic-assisted laparoscopic radical prostatectomy.	Up to 18 months post surgery
Secondary	Patient-Assessed Changes in Health-Related Quality of Life (HRQOL) - Expanded Prostate Cancer Index Composite (EPIC)	Administered prior to SBRT, and at 2 weeks, 4 weeks, 2 months and then every 3 months up to 18 months post-prostatectomy. The 26-item, short-form version of the Expanded Prostate Cancer Index Composite (EPIC) is a validated questionnaire used to assess HRQOL in prostate cancer patients. EPIC includes 4 domains: urinary, bowel, sexual, and hormonal. There are summary, i.e., overall, scores and function and bother subscale scores for each of the 4 domains. The urinary domain has 2 additional subscales: incontinence and irritative/obstructive. Domains and subscales are scored using a 0-100 grading system, with a higher score indicating a better quality of life.	Up to 18 months post surgery
Secondary	Patient-Assessed Changes in HRQOL - International Prostate Symptom Score (IPSS)	Administered prior to SBRT, and at 2 weeks, 4 weeks, 2 months and then every 3 months up to 18 months post-prostatectomy. The IPSS will be used to assess changes in urinary toxicity. Scoring is 0, 1, 2, 3, 4, 5 per question, Total IPSS Score out of 35 points from 7 questions. Descriptive summaries of scores at baseline and each subsequent follow up will include means and standard deviations.	Up to 18 months post surgery
Secondary	Patient-Assessed Changes in HRQOL - Rectal Assessment Scale (RAS)	Administered prior to SBRT, and at 2 weeks, 4 weeks, 2 months and then every 3 months up to 18 months post-prostatectomy. The RAS will be used to assess changes in rectal toxicity. Scoring is 0, 1, 2, 3 per question, Total RAS Score out of 15 points from 5 questions. Descriptive summaries of scores at baseline and each subsequent follow up will include means and standard deviations.	Up to 18 months post surgery
Secondary	Patient-Assessed Changes in HRQOL - Sexual Health Inventory for Men (SHIM)	Administered prior to SBRT, and at 2 weeks, 4 weeks, 2 months and then every 3 months up to 18 months post-prostatectomy. The SHIM will be used to assess changes in sexual toxicity. Scoring is 0, 1, 2, 3, 4, 5 per question, Total SHIM score out of 25 points from 5 questions. Descriptive summaries of scores at baseline and each subsequent follow up will include means and standard deviations.	Up to 18 months post surgery

External Links

•   Moffitt Cancer Center Clinical Trials website