SBRT for Organ Confined Prostate Cancer

NCT ID: NCT02653248

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2021-12-31

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.

Detailed Description

Radiation options for treating early stage prostate cancer can include external radiation therapy, which is radiation given outside the body, or prostate seed implant, which is placing radioactive seeds directly into the prostate. For external beam radiation therapy, treatment can last up to 9 weeks. Treatment is given daily, Monday through Friday. This may not be the most convenient option for some patients.

One way to potentially overcome this challenge is to deliver a more intense dose of radiation treatment to the tumor over a shorter amount of time. Stereotactic Body Radiation Therapy (SBRT) is a technique that treats the prostate with fewer treatments and can decrease the effect of radiation to the surrounding tissues. This study is a Phase I research study, which means that it will look at the safety of the dose of the SBRT. While SBRT itself is a standard of care method to administer radiation therapy, there has not been a specific dose outlined in the past. The aim of this study is to determine the dose that will treat the prostate cancer but cause the least amount of side effects.

Conditions

Adenocarcinoma; Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

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.

Group Type: EXPERIMENTAL

Stereotactic Body Radiation Therapy

Intervention Type: 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.

Cohort 2

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.

Group Type: EXPERIMENTAL

Stereotactic Body Radiation Therapy

Intervention Type: 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.

Cohort 3

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.

Group Type: EXPERIMENTAL

Stereotactic Body Radiation Therapy

Intervention Type: 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.

Interventions

Stereotactic Body Radiation Therapy

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.

Intervention Type: RADIATION

Other Intervention Names

SBRT

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
• Acquired Immune Deficiency Syndrome (AIDS) based upon current Center Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
• History of treatment with potent immunosuppressive drugs for such conditions as post organ transplant, severe rheumatoid arthritis, etc. within the past 6 months.

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

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Louis Potters

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Louis Potters, MD

Role: PRINCIPAL_INVESTIGATOR

North Shore-LIJ

Locations

North Shore-LIJ Cancer Institute

Lake Success, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30721721 (View on PubMed)

Other Identifiers

10-128B

Identifier Type: -

Identifier Source: org_study_id