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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02946008
• Other study ID #: UMCC 2016.106
• Secondary ID: HUM00120414
• Status: Completed
• Phase: Phase 1
• Start date: March 27, 2017
• Est. completion date: July 12, 2019

Study information

• Verified date: November 2019
• Source: University of Michigan Rogel Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 12, 2019
• Est. primary completion date: April 10, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Stereotactic Body Radiation Therapy
Delivered over 5 treatment sessions for approximately 1.5 weeks total.

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

Locations

Country	Name	City	State
United States	The University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6-week post-prostatectomy
Secondary	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)	up to one year post treatment
Secondary	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.)	up to one year post treatment
Secondary	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.)	up to one year post treatment
Secondary	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.)	up to one year post treatment
Secondary	Number of Patients with Positive Surgical Margins	Surgical specimens will be evaluated by the study pathologist to determine rate of margin positivity.	4-10 weeks post radiation therapy
Secondary	Number of Patients with Extracapsular Extension	Surgical specimens will be evaluated by the study pathologist to determine rate of extracapsular extension.	4-10 weeks post radiation therapy