SBRT for Organ Confined Prostate Cancer

NCT02653248 | Completed Phase 1 DMC

• 1 other identifier: 10-128B
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Stereotactic Body Radiation Therapy (SBRT) is a method of delivering radiation which can target the tumor more precisely and cause less damage to normal tissue. This is a Phase I research study looking at the safety of the dose of SBRT in organ confined prostate cancer.

Conditions

Adenocarcinoma; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose

  Patients in each dose cohort will all be treated as a single dose group for dose escalation. Each cohort will have 7-15 patients. The study will be completed when either of the following events occur: 1- The Maximum Tolerated Dose (MTD) for a cohort is reached or 2- when the highest protocol dose level is treated and tolerated (10 Gy/fraction, total 50 Gy) where we consider the therapy likely to be tumoricidal per determination of the investigators. Follow up assessments will be: 1.5 months post treatment, 3, 6, 9, and 12 months post treatment, then every 6 months until five years post treatment, then annually for years 5-10. A period of 90 days must pass in order to assess toxicity. If 90 days have transpired without Dose Limiting Toxicity (DLT) in each of the first seven patients enrolled to a specific dose level, then dose escalation to the next level may proceed.

  Up to 10 years

Secondary Outcomes (8)

• Measurement of response - No Evidence of Disease

  Up to 10 years

• Measurement of response - Equivocal Disease

  Up to 10 years

• Measurement of response - Radiographic Evidence of Disease

  Up to 10 years

• Time to Biochemical failure

  Up to 10 years

• Disease-Free Interval

  Up to 10 years

Study Arms (3)

Cohort 1

EXPERIMENTAL

Patients will receive 5 fractions of Stereotactic Body Radiation Therapy (SBRT). Dose per fraction is 8Gy. Total Dose: 40Gy. To escalate the dose of stereotactic radiotherapy to a tumoricidal dose without exceeding the maximum tolerated dose in patients with organ confined prostate cancer.

Radiation: Stereotactic Body Radiation Therapy

Cohort 2

EXPERIMENTAL

Patients will receive 5 fractions of Stereotactic Body Radiation Therapy (SBRT). Dose per fraction is 9Gy. Total Dose: 45 Gy. To escalate the dose of stereotactic radiotherapy to a tumoricidal dose without exceeding the maximum tolerated dose in patients with organ confined prostate cancer.

Radiation: Stereotactic Body Radiation Therapy

Cohort 3

EXPERIMENTAL

Patients will receive 5 fractions of Stereotactic Body Radiation Therapy (SBRT). Dose per fraction is 10Gy. Total Dose: 50Gy. To escalate the dose of stereotactic radiotherapy to a tumoricidal dose without exceeding the maximum tolerated dose in patients with organ confined prostate cancer.

Radiation: Stereotactic Body Radiation Therapy

Interventions

Stereotactic Body Radiation Therapy RADIATION

Patients will receive 5 fractions of SBRT radiation, treated every other day. No more than three fractions per week. Total dose will depend on cohort. Cohort 1: 40Gy, Cohort 2: 45 Gy, Cohort 3: 50 Gy.

Also known as: SBRT

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

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

You may qualify if:

• Willing and capable to provide informed consent
• Signed study specific informed consent
• Prostate specific-antigen (PSA) ≤ 10 Gleason 2-7
• Appropriate staging studies identifying as American Joint Committee on Cancer (AJCC) stage T1a, T1b, T1c, T2a, T2b
• No direct evidence of regional or distant metastases after appropriate staging studies
• Histologic confirmation of cancer by biopsy
• Age ≥ 18
• Karnofsky Performance Status must be ≥ 70
• American Urological Association (AUA) score must be ≤ 15 (alpha blockers allowed)

You may not qualify if:

• Female
• Positive lymph nodes of metastatic disease from prostate cancer
• Prior invasive malignancy unless disease free for a minimum of 3 years (carcinoma in situ of the breast, oral cavity, or non-melanomatous skin cancer are all permissable)
• T2c, T3, or T4 tumors
• Previous pelvic radiotherapy
• Previous surgery or chemotherapy for prostate cancer
• Previous transurethral resection of the prostate (TURP) or cryotherapy to the prostate
• Concomitant hormonal therapy
• Concomitant antineoplastic therapy (including surgery, cryotherapy, conventionally fractionated radiotherapy, and chemotherapy) while on this protocol
• History of Crohn's Disease or Ulcerative Colitis
• Previous significant obstructive symptoms; AUA score must be ≤ 15 (alpha blockers allowed)
• Significant psychiatric illness
• Severe, active co-morbidity defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months.
• Transmural myocardial infarction within the last 6 months

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

North Shore-LIJ Cancer Institute

Lake Success, New York, 11042, United States

Location

Related Publications (1)

• Potters L, Rana Z, Lee L, Cox BW. Outcomes of a Dose-Escalated Stereotactic Body Radiation Phase 1 Trial for Patients With Low- and Intermediate-Risk Prostate Cancer. Int J Radiat Oncol Biol Phys. 2019 Jun 1;104(2):334-342. doi: 10.1016/j.ijrobp.2019.01.092. Epub 2019 Feb 2.

  PMID: 30721721 DERIVED

MeSH Terms

Conditions

Adenocarcinoma; Prostatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; 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

• Louis Potters, MD

  North Shore-LIJ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 26, 2015
• First Posted: January 12, 2016
• Study Start: August 1, 2010
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2021
• Last Updated: February 9, 2022

Record last verified: 2022-02

Locations

US (1)