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

NCT03748719 | Withdrawn FDA Device

• 1 other identifier: MCC-19670
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate Cancer

Keywords

High Risk Prostate Cancer; prostate; radiation therapy

Outcome Measures

Primary Outcomes (2)

• 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

• Number of symptomatic adverse anastomotic events

  Number of symptomatic anastomotic events related to pre-operative SBRT.

  Up to 12 months

Secondary Outcomes (3)

• Mean Catheterization Time

  Up to 4 weeks post surgery

• Mean Hospital Stay

  Up to 2 week post surgery

• Quality of Life assessment

  Baseline, at 2 weeks, 4 weeks, 2 months and every 3 months up to 12 months post surgery

Study Arms (1)

Stereotactic Body Radiation Therapy, followed by Prostatectomy

EXPERIMENTAL

Patients will receive 6 Gy per day of Stereotactic Body Radiation Therapy (SBRT) per day for 5 days, followed by prostatectomy in 3 weeks.

Device: Stereotactic Body Radiation Therapy (SBRT)

Interventions

Stereotactic Body Radiation Therapy (SBRT) DEVICE

SBRT treatment

Stereotactic Body Radiation Therapy, followed by Prostatectomy

Eligibility Criteria

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

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery

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)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Peter Johnstone, MD

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 21, 2018
• Study Start: November 19, 2018
• Primary Completion: October 15, 2019
• Study Completion: December 4, 2019
• Last Updated: May 22, 2020

Record last verified: 2020-05