Phase I Study of Stereotactic Body Radiation Therapy (SBRT) for Organ Confined Prostate Cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Adenocarcinoma
- Sponsor
- Northwell Health
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Maximum tolerated dose
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Louis Potters
MD
Northwell Health
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
- •Karnofsky Performance Status must be ≥ 70
- •American Urological Association (AUA) score must be ≤ 15 (alpha blockers allowed)
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Maximum tolerated dose
Time Frame: Up to 10 years
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 Outcomes
- Time to Distant Failure(Up to 10 years)
- Disease-Specific Survival(Up to 10 years)
- Measurement of response - Radiographic Evidence of Disease(Up to 10 years)
- Disease-Free Interval(Up to 10 years)
- Time to Biochemical failure(Up to 10 years)
- Measurement of response - No Evidence of Disease(Up to 10 years)
- Measurement of response - Equivocal Disease(Up to 10 years)
- Overall Survival(Up to 10 years)