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Clinical Trials/NCT02946008
NCT02946008CompletedPhase 1

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

University of Michigan Rogel Cancer Center2 sites in 1 country17 target enrollmentStarted: March 27, 2017Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
17
Locations
2
Primary Endpoint
Maximum Tolerated Dose (MTD) of Neoadjuvant SBRT
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

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.
  • •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): ≥
  • •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.

Outcomes

Primary Outcomes

Maximum Tolerated Dose (MTD) of Neoadjuvant SBRT

Time Frame: 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 Outcomes

  • Incidence of Urinary Stricture(up to one year post treatment)
  • Number of Patients with Positive Surgical Margins(4-10 weeks post radiation therapy)
  • Rectal Toxicity(up to one year post treatment)
  • Number of Patients with Extracapsular Extension(4-10 weeks post radiation therapy)
  • Incidence of Urinary Incontinence(up to one year post treatment)
  • Incidence of Urinary Bother(up to one year post treatment)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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