Feasibility and Safety Study Using Preoperative High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy at High-Risk for Extraprostatic Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Withdrawn; Phase 1

Conditions: Prostate Cancer

Treatments: Radiation: High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01163448

09-013

Details and patient eligibility

About

This study is being done to test the safety of a single high-dose of radiation therapy before radical prostatectomy (removal of the prostate). The investigators want to find out what effects, good and/or bad, the radiation will have on men undergoing prostatectomy. The investigators are especially interested in men who are at risk for having cancer cells that have spread outside the prostate.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Biopsy-proven prostate cancer verified at MSKCC. The biopsy will include a minimum of 10 cores
• Radical Prostatectomy (RP) chosen as the therapeutic method
• The size of the prostate will be < 70 cc by transrectal ultrasound or endorectal MRI imaging
• No radiographic evidence of lymph node metastases, bone metastases or soft tissue disease
• Risk of extraprostatic cancer of > 40% based on the MSKCC surgical nomogram
• Age > or = to 18 years
• KPS > or = to 80
• Able to tolerate immobilization cradle positioning

Exclusion criteria

• Allergic reaction to intravenous CT contrast (if premedicated, pt will not be excluded)
• Prior radiation to the planned target region
• Patients receiving concurrent chemotherapy
• Neoadjuvant hormonal therapy Luteinizing-hormone-releasing hormone(LHRH)agonist and/or antiandrogen)
• Prior transurethral resection of the prostate
• Normal tissue directly overlying target precluding ability to limit the bowel, bladder, rectum or other tissue to less than or equal to 15-16 Gy dose constraints
• Dominant prostatic lesion within 3 mm from the anterior rectal wall by imaging studies
• Creatinine clearance <60 ml/min/1.73m2

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

High-Dose Single-Fraction Image-Guided Radiotherapy

Experimental group

Description:

This will assess the feasibility and safety of this approach in men at high-risk for extraprostatic prostate cancer undergoing RP. This initial trial has been designed in a manner intended to emphasize patient comfort and safety.

Treatment:

Radiation: High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy