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SBRT for Organ Confined Prostate Cancer

Primary Purpose

Adenocarcinoma, Prostate Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Stereotactic Body Radiation Therapy

About this trial

This is an interventional treatment trial for Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

North Shore-LIJ Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Measurement of response - No Evidence of Disease

No clinical evidence of disease on digital rectal examination.

Measurement of response - Equivocal Disease

If abnormalities are present on the prostate digital rectal examination but are thought to be abnormal due to treatment and felt not to represent tumor. If clinical evidence of residual tumor is present but this has regressed from a previous examination.

Measurement of response - Radiographic Evidence of Disease

Radiographic evidence of hematogenous (osseous, hepatic, etc.) and/or extrapelvic lymphatic of soft tissue relapse. Radiographic evidence of tumor recurrence within the pelvic lymphatics or soft tissue beneath the bifurcation of the common iliac arteries.

Time to Biochemical failure

Prostate Specific Antigen (PSA) levels should be obtained per study calendar. The RTOG-ASTRO definition (also known as the Phoenix definition) of PSA failure will be used. Thus, when the PSA rises by more than 2 ng/ml above the lowest level (nadir) achieved after treatment, biochemical failure has occurred and the date of the failure is recorded at the time the nadir plus 2 ng/ml level is reached.

Disease-Free Interval

The disease-free interval will be measured from the date of accession to the date of documentation of progression or until the date of death (from other causes).

Time to Distant Failure

The time to distant failure will be measured from the date of study entry to the date of documented regional nodal recurrence or distant disease relapse. Patients with evidence of biochemical failure, but a negative prostate biopsy, will be considered as distant failure only.

Overall Survival

The survival time will be measured from the date of accession to the date of death. All patients will be followed for survival. Every effort should be made to document the cause of death

Disease-Specific Survival

Disease-specific survival will be measured from the date of study entry to the date of death due to prostate cancer. The following will be considered as failure events in assessing disease specific survival.

Full Information

NCT ID

NCT02653248

First Posted

August 26, 2015

Last Updated

February 7, 2022

Sponsor

Northwell Health

1. Study Identification

Unique Protocol Identification Number

NCT02653248

Brief Title

SBRT for Organ Confined Prostate Cancer

Official Title

Phase I Study of Stereotactic Body Radiation Therapy (SBRT) for Organ Confined Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

June 2018 (Actual)

Study Completion Date

December 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwell Health

4. Oversight

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenocarcinoma, Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

Arm Title

Cohort 3

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Body Radiation Therapy

Other Intervention Name(s)

SBRT

Intervention Description

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 Outcome Measure Information:

Title

Maximum tolerated dose

Description

Time Frame

Up to 10 years

Secondary Outcome Measure Information:

Title

Measurement of response - No Evidence of Disease

Description

No clinical evidence of disease on digital rectal examination.

Time Frame

Up to 10 years

Title

Measurement of response - Equivocal Disease

Description

Time Frame

Up to 10 years

Title

Measurement of response - Radiographic Evidence of Disease

Description

Time Frame

Up to 10 years

Title

Time to Biochemical failure

Description

Time Frame

Up to 10 years

Title

Disease-Free Interval

Description

The disease-free interval will be measured from the date of accession to the date of documentation of progression or until the date of death (from other causes).

Time Frame

Up to 10 years

Title

Time to Distant Failure

Description

Time Frame

Up to 10 years

Title

Overall Survival

Description

The survival time will be measured from the date of accession to the date of death. All patients will be followed for survival. Every effort should be made to document the cause of death

Time Frame

Up to 10 years

Title

Disease-Specific Survival

Description

Time Frame

Up to 10 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Louis Potters, MD

Organizational Affiliation

North Shore-LIJ

Official's Role

Principal Investigator

Facility Information:

Facility Name

North Shore-LIJ Cancer Institute

City

Lake Success

State/Province

New York

ZIP/Postal Code

11042

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30721721

Citation

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.

Results Reference

derived

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SBRT for Organ Confined Prostate Cancer

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