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Neoadjuvant Stereotactic Body Radiotherapy Prior to Radical Prostatectomy for High Risk Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Stereotactic Body Radiation Therapy

Radical Prostatectomy

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Subjects must have biopsy-confirmed adenocarcinoma of the prostate.
Subjects must have a negative bone scan.
Subjects must have one of the following risk factors:
PSA ≥20 and/or
Gleason score ≥8 and/or
Clinical or radiographic stage ≥T3a per AJCC (American Joint Committee on Cancer) 7th Edition Staging Manual and/or
Radiographic pelvic lymph node positive disease and/or
At least two out of four of the following: PSA (Prostate Specific Antigen) 10-19.9, GS (Gleason Score) = 3+4, clinical stage = T2b/T2c, ≥50% positive biopsy cores.
Subjects must freely sign informed consent to enroll in the study.
Subjects must be medically fit to undergo surgery determined by the PI.
Age ≥ 18
KPS Karnofsky Performance Status (performance status is an attempt to quantify cancer patients' general well-being and activities of daily life, scores range from 0 to 100 where 100 represents perfect health and 0 represents death): ≥70.
No prior invasive malignancy in the past 3-years, except non-melanomatous skin cancer unless disease free for a minimum of 2 years. Carcinoma in-situ of the bladder or head and neck region is permissible.
Subjects must not have had prior pelvic radiation therapy,
Subjects must not have had prior androgen deprivation therapy in the past 6 months.

Exclusion Criteria:

Metastatic disease as demonstrated by bone scan, CT scan or MRI (Magnetic Resonance Imaging) of the pelvis, or chest x-ray.
Declared high-risk for anesthesia by attending anesthesiologist, cardiologist, or other physician.
History of prior pelvic radiation therapy.
History of androgen deprivation therapy within the past 6 months.

Sites / Locations

The University of Michigan Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SBRT

Arm Description

Stereotactic Body Radiation Therapy (SBRT) will be delivered over 5 treatment sessions for approximately 1.5 weeks total.

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose (MTD) of Neoadjuvant SBRT

The MTD is defined as the SBRT dose that with radical prostatectomy induces dose-limiting toxicity in 28% of subjects or less.

Secondary Outcome Measures

Incidence of Urinary Incontinence

Urinary incontinence will be scored according to Common Toxicity Criteria for Adverse Events (CTCAE) v.4.0 (Grade 1 = Occasional, Grade 2 = Spontaneous, pads indicated, Grade 3 = Intervention indicated)

Incidence of Urinary Stricture

Urinary stricture, according to Common Toxicity Criteria for Adverse Events (CTCAE) v.4.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening, Grade 5 = death.)

Incidence of Urinary Bother

Urinary bother, according to Common Toxicity Criteria for Adverse Events (CTCAE) v.4.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening, Grade 5 = death.)

Rectal Toxicity

Rectal Toxicity, according to Common Toxicity Criteria for Adverse Events (CTCAE) v.4.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening, Grade 5 = death.)

Number of Patients with Positive Surgical Margins

Surgical specimens will be evaluated by the study pathologist to determine rate of margin positivity.

Number of Patients with Extracapsular Extension

Surgical specimens will be evaluated by the study pathologist to determine rate of extracapsular extension.

Full Information

NCT ID

NCT02946008

First Posted

October 25, 2016

Last Updated

November 25, 2019

Sponsor

University of Michigan Rogel Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT02946008

Brief Title

Neoadjuvant Stereotactic Body Radiotherapy Prior to Radical Prostatectomy for High Risk Prostate Cancer

Official Title

A Phase I Trial of Neoadjuvant Stereotactic Body Radiotherapy Prior to Radical Prostatectomy for High Risk Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

March 27, 2017 (Actual)

Primary Completion Date

April 10, 2018 (Actual)

Study Completion Date

July 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Michigan Rogel Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a single-arm prospective non-randomized, non-blinded trial to assess the safety of neoadjuvant stereotactic body radiation therapy (SBRT) before surgery in high risk prostate cancer patients. Radiation therapy will be delivered over 5 treatment sessions for approximately 1.5 weeks total.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SBRT

Arm Type

Experimental

Arm Description

Stereotactic Body Radiation Therapy (SBRT) will be delivered over 5 treatment sessions for approximately 1.5 weeks total.

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Body Radiation Therapy

Intervention Description

Delivered over 5 treatment sessions for approximately 1.5 weeks total.

Intervention Type

Procedure

Intervention Name(s)

Radical Prostatectomy

Intervention Description

Open, laparoscopic, or robotic radical prostatectomy and pelvic lymph node dissection to remove the prostate, seminal vesicles, and pelvic lymph nodes.

Primary Outcome Measure Information:

Title

Maximum Tolerated Dose (MTD) of Neoadjuvant SBRT

Description

The MTD is defined as the SBRT dose that with radical prostatectomy induces dose-limiting toxicity in 28% of subjects or less.

Time Frame

6-week post-prostatectomy

Secondary Outcome Measure Information:

Title

Incidence of Urinary Incontinence

Description

Time Frame

up to one year post treatment

Title

Incidence of Urinary Stricture

Description

Urinary stricture, according to Common Toxicity Criteria for Adverse Events (CTCAE) v.4.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening, Grade 5 = death.)

Time Frame

up to one year post treatment

Title

Incidence of Urinary Bother

Description

Urinary bother, according to Common Toxicity Criteria for Adverse Events (CTCAE) v.4.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening, Grade 5 = death.)

Time Frame

up to one year post treatment

Title

Rectal Toxicity

Description

Rectal Toxicity, according to Common Toxicity Criteria for Adverse Events (CTCAE) v.4.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening, Grade 5 = death.)

Time Frame

up to one year post treatment

Title

Number of Patients with Positive Surgical Margins

Description

Surgical specimens will be evaluated by the study pathologist to determine rate of margin positivity.

Time Frame

4-10 weeks post radiation therapy

Title

Number of Patients with Extracapsular Extension

Description

Surgical specimens will be evaluated by the study pathologist to determine rate of extracapsular extension.

Time Frame

4-10 weeks post radiation therapy

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects must have biopsy-confirmed adenocarcinoma of the prostate. Subjects must have a negative bone scan. Subjects must have one of the following risk factors: PSA ≥20 and/or Gleason score ≥8 and/or Clinical or radiographic stage ≥T3a per AJCC (American Joint Committee on Cancer) 7th Edition Staging Manual and/or Radiographic pelvic lymph node positive disease and/or At least two out of four of the following: PSA (Prostate Specific Antigen) 10-19.9, GS (Gleason Score) = 3+4, clinical stage = T2b/T2c, ≥50% positive biopsy cores. Subjects must freely sign informed consent to enroll in the study. Subjects must be medically fit to undergo surgery determined by the PI. Age ≥ 18 KPS Karnofsky Performance Status (performance status is an attempt to quantify cancer patients' general well-being and activities of daily life, scores range from 0 to 100 where 100 represents perfect health and 0 represents death): ≥70. No prior invasive malignancy in the past 3-years, except non-melanomatous skin cancer unless disease free for a minimum of 2 years. Carcinoma in-situ of the bladder or head and neck region is permissible. Subjects must not have had prior pelvic radiation therapy, Subjects must not have had prior androgen deprivation therapy in the past 6 months. Exclusion Criteria: Metastatic disease as demonstrated by bone scan, CT scan or MRI (Magnetic Resonance Imaging) of the pelvis, or chest x-ray. Declared high-risk for anesthesia by attending anesthesiologist, cardiologist, or other physician. History of prior pelvic radiation therapy. History of androgen deprivation therapy within the past 6 months.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Spratt, M.D.

Organizational Affiliation

University of Michigan Rogel Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Michigan Comprehensive Cancer Center

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Neoadjuvant Stereotactic Body Radiotherapy Prior to Radical Prostatectomy for High Risk Prostate Cancer

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