Clinical trial NCT02946008: Neoadjuvant Stereotactic Body Radiotherapy Prior to Radical Prostatectomy for High Risk Prostate Cancer
Official title: A Phase I Trial of Neoadjuvant Stereotactic Body Radiotherapy Prior to Radical Prostatectomy for High Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) of Neoadjuvant SBRT
timeFrame: 6-week post-prostatectomy
Secondary outcomes:
measure: Incidence of Urinary Incontinence
timeFrame: up to one year post treatment
measure: Incidence of Urinary Stricture
timeFrame: up to one year post treatment
measure: Incidence of Urinary Bother
timeFrame: up to one year post treatment
measure: Rectal Toxicity
timeFrame: up to one year post treatment
measure: Number of Patients with Positive Surgical Margins
timeFrame: 4-10 weeks post radiation therapy
measure: Number of Patients with Extracapsular Extension
timeFrame: 4-10 weeks post radiation therapy
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Daniel Spratt, M.D.
role: PRINCIPAL_INVESTIGATOR
References: