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NCT Number: NCT00911118

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

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Hypofractionated, image-guided, intensity-modulated external beam radiation

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.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Montefiore Medical Center

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2026
Study completion
2026
First posted
Jun 1, 2009
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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