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

Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Radiation: Stereotactic Body Radiation Therapy; Procedure: Radical Prostatectomy

• Registration Number: NCT02946008
• Lead Sponsor: University of Michigan Rogel Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-26
• Study Start: 2017-03-27
• Primary Completion: 2018-04-10
• Study Completion: 2019-07-12
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-25
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD) of Neoadjuvant SBRT	6-week post-prostatectomy	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

Name	Time	Method
Incidence of Urinary Stricture	up to one year post treatment	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.)
Number of Patients with Positive Surgical Margins	4-10 weeks post radiation therapy	Surgical specimens will be evaluated by the study pathologist to determine rate of margin positivity.
Rectal Toxicity	up to one year post treatment	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 Extracapsular Extension	4-10 weeks post radiation therapy	Surgical specimens will be evaluated by the study pathologist to determine rate of extracapsular extension.
Incidence of Urinary Incontinence	up to one year post treatment	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 Bother	up to one year post treatment	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.)

Trial Locations

Locations (1)

The University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States