Clinical trial NCT02546427: Hypofractionated Whole Pelvic Radiotherapy of the Prostate
Official title: Phase I Feasibility Study of Accelerated Hypofractionated Whole Pelvic Radiotherapy for Patients With Intermediate-High Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2015-09-10
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase I feasibility study to evaluate the feasibility of hypofractionated whole pelvis radiotherapy in 35 patients with biopsy-proven intermediate- to high-risk prostate cancer as defined by NCCN risk criteria. Patients will have \>15% risk of lymph node involvement as defined by the Roach equation 2/3(PSA)+10(Gleason Score-6). Day 0 of the study will be defined as the time of first LHRH/agonist/antagonist injection of hormone therapy. Radiation therapy should begin within 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection. Patients will be followed at 6 weeks and then every 3 months for the first 24 months after completion of radiotherapy in a similar schedule to usual standard of care. A history and physical, PSA, testosterone and EPIC-26 questionnaire will be collected at each visit. Any toxicity according to CTCAE v. 4.0 criteria will be documented. An interim analysis for evaluating acute toxicity (≤90 days) will be performed after the first follow-up visit of the20th patient enrolled on protocol. The trial will be terminated if \>30% acute grade 2 or \>5% grade 3 or greater toxicity is observed as a result of radiation treatment by CTCAE v. 4.0 criteria. Grade 2 toxicity is defined as a minimal, local or noninvasive intervention. Grade 3 toxicity is defined as a severe or medically significant but not immediately life-threatening event requiring hospitalization or prolongation of hospitalization. Previous studies have demonstrated approximately 30% and 5% incidence of Grade 2 and Grade 3 or greater toxicity, respectively, with conventionally fractionated radiotherapy followed by brachytherapy.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed intermediate- to high-risk prostate adenocarcinoma (T1c-T3b, PSA \>10, and/or Gleason score ≥ 7) who have a greater than 15% risk of lymph node involvement as determined by the Roach equation.
* History/physical examination with digital rectal examination of the prostate within 8 weeks prior to registration
* Zubrod performance status 0-2
* Age ≥18 years
* Ability to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria:

* Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years.
* Evidence of distant metastases
* Regional lymph node involvement
* Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
* Previous pelvic irradiation, prostate brachytherapy
* Previous or concurrent cytotoxic chemotherapy for prostate cancer
* Patients with history of inflammatory bowel disease or major bowel surgery.
* Prior transurethral resection of the prostate (TURP) procedure.

Primary outcomes:
measure: Toxicity
timeFrame: 90 days post treatment
Secondary outcomes:
measure: Late Toxicity
timeFrame: From 90 days post treatment until 36 months from start of therapy
measure: High-Related Quality of Life (HRQOL)
timeFrame: Baseline, week prior to RT, 6 weeks post treatment, and at least every 6 months for the first 2 years.
measure: PSA Complete Response (PSA-CR)
timeFrame: 120-127 days after initiation of therapy
Other outcomes:
Locations:
Study officials:
References: