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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer; Adenocarcinoma	Radiation: Hypofractionated, image-guided, intensity-modulated external beam radiation	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	120 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase I Dose Escalation Study Using Ultra-Hypofractionated, Image-Guided, Intensity-Modulated Radiotherapy in Prostate Cancer
Actual Study Start Date :	May 2009
Estimated Primary Completion Date :	May 2018
Estimated Study Completion Date :	May 2018

Arms and Interventions

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Arm

Intervention/treatment

Experimental: 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.

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.

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

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Locations

United States, New York
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
Memorial Sloan Kettering West Harrison
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York, United States
Memoral Sloan Kettering Cancer Center@Phelps
Sleepy Hollow, New York, United States
Montefiore Medical Center
The Bronx, New York, United States, 10467

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

Montefiore Medical Center

Investigators

Principal Investigator:	Michael Zelefsky, MD	Memorial Sloan Kettering Cancer Center

More Information

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Additional Information:

Memorial Sloan-Kettering Cancer Center 

Responsible Party:	Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00911118 History of Changes
Other Study ID Numbers:	09-035
First Posted:	June 1, 2009
Last Update Posted:	June 2, 2017
Last Verified:	June 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:

prostate; radiation; 09-035

Additional relevant MeSH terms:

Prostatic Neoplasms; Adenocarcinoma; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms	Genital Diseases, Male; Prostatic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type