Dose Escalation Study of Preoperative SBRT for High Risk Prostate Cancer

NCT02572284 | Completed Phase 1

• 1 other identifier: MCC-18201
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Stereotactic Body Radiation Therapy (SBRT); High Risk Prostate Cancer; Preoperative SBRT; Prostate Adenocarcinoma; Prostatectomy; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Occurrence of Late Toxicity

  90+ days after start of radiotherapy

• Mean Catheterization Time for Study Participants

  Up to 18 months post surgery

• Mean Hospital Stay for Study Participants

  Up to 18 months post surgery

• Reoperation Rate for Study Participants

  Up to 18 months post surgery

• Patient-Assessed Changes in Health-Related Quality of Life (HRQOL) - Expanded Prostate Cancer Index Composite (EPIC)

  Up to 18 months post surgery

Study Arms (1)

Dose Escalation of SBRT

EXPERIMENTAL

Stereotactic Body Radiation Therapy (SBRT) followed by prostatectomy and Quality of Life questionnaires. The radiation will be given for only 5 days. Conventional radiation to the prostate is given over 7-8 weeks.

Radiation: Stereotactic Body Radiation Therapy (SBRT); Procedure: Prostatectomy; Other: Quality of Life Questionnaires

Interventions

Stereotactic Body Radiation Therapy (SBRT) RADIATION

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.

Also known as: radiation therapy

Dose Escalation of SBRT

Prostatectomy PROCEDURE

About 4-6 weeks after SBRT, participants will have a prostatectomy.

Also known as: surgery

Dose Escalation of SBRT

Quality of Life Questionnaires OTHER

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.

Also known as: questionnaire

Dose Escalation of SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery; Radiotherapy; Prostatectomy; Surgical Procedures, Operative; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Investigative Techniques; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Peter Johnstone, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

• Julio Pow-Sang, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: October 8, 2015
• Study Start: January 27, 2016
• Primary Completion: July 5, 2018
• Study Completion: October 23, 2019
• Last Updated: January 19, 2023

Record last verified: 2023-01

Locations

US (1)