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

NCT02946008 | Completed Phase 1 DMC FDA Device

• 2 other identifiers: UMCC 2016.106HUM00120414
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Incidence of Urinary Incontinence

  up to one year post treatment

• Incidence of Urinary Stricture

  up to one year post treatment

• Incidence of Urinary Bother

  up to one year post treatment

• Rectal Toxicity

  up to one year post treatment

• Number of Patients with Positive Surgical Margins

  4-10 weeks post radiation therapy

Study Arms (1)

SBRT

EXPERIMENTAL

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

Radiation: Stereotactic Body Radiation Therapy; Procedure: Radical Prostatectomy

Interventions

Stereotactic Body Radiation Therapy RADIATION

Delivered over 5 treatment sessions for approximately 1.5 weeks total.

SBRT

Radical Prostatectomy PROCEDURE

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

SBRT

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

The University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Hammer L, Jiang R, Hearn J, Lashbrook J, Mitchell A, Daignault-Newton S, Dess RT, Jackson WC, Reichert Z, Alumkal JJ, Kaffenberger S, George A, Montgomery J, Salami SS, Morgan TM, Miller D, Wittman D, Hollenbeck B, Mehra R, Davenport MS, Sun Y, Schipper M, Palapattu G, Spratt DE. A Phase I Trial of Neoadjuvant Stereotactic Body Radiotherapy Prior to Radical Prostatectomy for Locally Advanced Prostate Cancer. Int J Radiat Oncol Biol Phys. 2023 Jan 1;115(1):132-141. doi: 10.1016/j.ijrobp.2022.07.016. Epub 2022 Jul 22.

  PMID: 35878714 DERIVED

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

• Daniel Spratt, M.D.

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: October 26, 2016
• Study Start: March 27, 2017
• Primary Completion: April 10, 2018
• Study Completion: July 12, 2019
• Last Updated: November 27, 2019

Record last verified: 2019-11

Locations

US (1)