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

NCT ID: NCT02946008

Last Updated: 2019-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-27
• Study Completion Date: 2019-07-12

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SBRT

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

Group Type: EXPERIMENTAL

Stereotactic Body Radiation Therapy

Intervention Type: RADIATION

Delivered over 5 treatment sessions for approximately 1.5 weeks total.

Radical Prostatectomy

Intervention Type: PROCEDURE

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

Interventions

Stereotactic Body Radiation Therapy

Delivered over 5 treatment sessions for approximately 1.5 weeks total.

Intervention Type: RADIATION

Radical Prostatectomy

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Spratt, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

The University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35878714 (View on PubMed)

Other Identifiers

HUM00120414

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2016.106

Identifier Type: -

Identifier Source: org_study_id