Dose Escalation Study Using Ultra-Hypofractionated, Image-Guided, Intensity-Modulated Radiotherapy in Prostate Cancer

Phase 1

Active, not recruiting

• Conditions: Adenocarcinoma; Prostate Cancer
• Interventions: Radiation: Hypofractionated, image-guided, intensity-modulated external beam radiation

• Registration Number: NCT00911118
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of this study is to test the safety of a new type of IG-IMRT called "ultra-hypofractionated IG-IMRT" where a higher dose of radiation is given to the tumor during each treatment day. Since higher doses of radiation are used each day, the total number of treatment days needed to complete this type of radiation is only five instead of the 45-48 treatments currently used. Treatment takes place every other day and is complete after 2 weeks. If the patient decides to get this treatment, they will come in for 5 treatments. This is different from the 48 treatments they would get normally.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-28
• Study First Submitted QC: 2009-05-28
• Study First Posted: 2009-06-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-18
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

Eligibility is not restricted to MSKCC to confirm biopsy/diagnosis. Participating institution testing is sufficient.

• Low and intermediate risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines.

• Low risk patients will be defined as:

  • PSA < or = to 10 ng/ml and
  • Gleason score = 6 and
  • Clinical Stage < or = to T2a

• Intermediate risk patients will be defined as:

  • PSA 10-20 ng/ml or
  • Gleason score = 7 or
  • Clinical stage T2b/T2c

Additionally, patients will be required to meet the following criteria:

• Age > or = to 18
• KPS > or = to 70
• Pre-treatment endorectal coil MRI or CT (MRI preferred) at MSKCC showing no definite evidence of radiographic T3, T4, or N1 disease
• Prostate size < or = to 60 cc
• International Prostate Symptom Score < or = to 15

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Exclusion Criteria

• Prior androgen deprivation therapy for prostate cancer

  • Elective pelvic lymph node irradiation

  • KPS < 70

  • Pelvic MRI or CT (MRI preferred) evidence of radiographic T3, T4 or N1 disease

  • Presence of distant metastasis as determined by:

    o alkaline phosphatase > or = to ULN or

  • whole body bone scan positive for osseous metastases

  • Prior history of transurethral resection of the prostate

  • Prior history of chronic prostatitis

  • Prior history of urethral stricture

  • Prior history of pelvic irradiation

  • History of inflammatory bowel disease

  • Unable to give informed consent

  • Unable to complete quality of life questionnaires Abnormal complete blood count. Any of the following

    • Platelet count less than 75,000/ml
    • Hb level less than 10 gm/dl
    • WBC less than 3.5/ml

  • Abnormal renal function tests (creatinine > 1.5)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiation	Hypofractionated, image-guided, intensity-modulated external beam radiation	Patients enrolled in the study will undergo image-guided, intensity-modulated radiotherapy using the same equipment, techniques, and treatment-planning procedures as currently practiced as MSKCC. MSKCC patients will have the option of continued follow-up through MSKCC's established Prostate Survivorship Clinic for an indefinite period of time, meaning patients enrolled in the protocol will be encouraged to remain at MSKCC for life-long follow-up after their treatment. The standard assessments obtained in the Survivorship Clinic will not be altered. All protocol relevant data collected at these visits through month 60 will be used for protocol analysis.

Primary Outcome Measures

Name	Time	Method
Assess the toxicity of hypofractionated radiation therapy as definitive treatment for low and intermediate risk prostate cancer.	With at least one status check visit during the course of treatment.

Secondary Outcome Measures

Name	Time	Method
Evaluate the effect of treatment on sexual function.	1, 3, & 6 months (+/- 4 weeks) Months 6 - 36 every 6 months (+/- 4 weeks)
Evaluate post-treatment PSA kinetics and incidence of PSA relapse free survival.	1, 3, & 6 months (+/- 4 weeks) Months 6 - 36 every 6 months (+/- 4 weeks)
Evaluate pathologic response rates at 24-36 months via repeat biopsy.	24-36 months post treatment

Trial Locations

Locations (7)

Memorial Sloan Kettering West Harrison; 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Cancer Center @ Suffolk; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering at Mercy Medical Center; 🇺🇸 Rockville Centre, New York, United States

Memorial Sloan Kettering Nassau; 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Cancer Center@Phelps; 🇺🇸 Sleepy Hollow, New York, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States