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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00911118
• Other study ID #: 09-035
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: May 2009
• Est. completion date: May 2025

Study information

• Verified date: September 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

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

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)

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Hypofractionated, image-guided, intensity-modulated external beam radiation
A standard dose escalation design is utilized, with the initial treatment assigned as 6.5 Gy/fraction for five fractions to a total dose of 32.5 Gy. For any given dose tier, an initial cohort of 30 patients will be treated. However to adjust for potentially inevaluable patients who dropout prior to a full toxicity collection to assess potential DLTs enrollment of up to five additional patients per cohort can occur, per PI's discretion. Dose escalation will proceed if < 10% of the 30 patients treated per tier exhibit any dose limiting toxicity (DLT) once the entire tier cohort has a minimum follow-up of 3 months and half the tier cohort has a minimum follow-up of 6 months. Dose escalation to the next tier will occur by increasing the dose per fraction by 0.5 Gy while keeping the fraction number constant at 5, leading to a total dose increase of 2.5 Gy per dose tier.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	Memorial Sloan Kettering Cancer Center @ Suffolk	Commack	New York
United States	Memorial Sloan Kettering West Harrison	Harrison	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering at Mercy Medical Center	Rockville Centre	New York
United States	Memorial Sloan Kettering Cancer Center@Phelps	Sleepy Hollow	New York
United States	Memorial Sloan Kettering Nassau	Uniondale	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Evaluate pathologic response rates at 24-36 months via repeat biopsy.		24-36 months post treatment
Secondary	Evaluate the effect of treatment on sexual function.		1, 3, & 6 months (+/- 4 weeks) Months 6 - 36 every 6 months (+/- 4 weeks)

External Links

•   Memorial Sloan-Kettering Cancer Center