Overview

This trial is active, not recruiting.

Conditions adenocarcinoma, prostate cancer
Treatment stereotactic body radiation therapy
Phase phase 1
Sponsor Northwell Health
Start date August 2010
End date June 2016
Trial size 36 participants
Trial identifier NCT02653248, 10-128B

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(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.
stereotactic body radiation therapy SBRT
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.
(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.
stereotactic body radiation therapy SBRT
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.
(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.
stereotactic body radiation therapy SBRT
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.

Primary Outcomes

Measure
Maximum tolerated dose
time frame: Up to 10 years

Secondary Outcomes

Measure
Measurement of response - No Evidence of Disease
time frame: Up to 10 years
Measurement of response - Equivocal Disease
time frame: Up to 10 years
Measurement of response - Radiographic Evidence of Disease
time frame: Up to 10 years
Time to Biochemical failure
time frame: Up to 10 years
Disease-Free Interval
time frame: Up to 10 years
Time to Distant Failure
time frame: Up to 10 years
Overall Survival
time frame: Up to 10 years
Disease-Specific Survival
time frame: Up to 10 years

Eligibility Criteria

Male participants at least 18 years old.

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.

Additional Information

Official title Phase I Study of Stereotactic Body Radiation Therapy (SBRT) for Organ Confined Prostate Cancer
Principal investigator Louis Potters, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Northwell Health.