Single Arm Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

A Single Arm Phase II Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03748719
• Other study ID #: MCC-19670
• Status: Withdrawn
• Phase: N/A
• Start date: November 19, 2018
• Est. completion date: December 4, 2019

Study information

• Verified date: May 2020
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 4, 2019
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Stereotactic Body Radiation Therapy (SBRT)
SBRT treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of PSA (Prostate Specific Antigen)	Measure of PSA through treatment. PSA is expected to be undetectable (<0.2 mg/ml) after prostatectomy and radiation therapy.	Up to 12 months
Primary	Number of symptomatic adverse anastomotic events	Number of symptomatic anastomotic events related to pre-operative SBRT.	Up to 12 months
Secondary	Mean Catheterization Time	Average time of catheterization following prostatectomy	Up to 4 weeks post surgery
Secondary	Mean Hospital Stay	Average time of hospitalization after prostatectomy	Up to 2 week post surgery
Secondary	Quality of Life assessment	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.	Baseline, at 2 weeks, 4 weeks, 2 months and every 3 months up to 12 months post surgery

External Links

•   Moffitt Cancer Center Clinical Trials Website