Hypofractionated SBRT For Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Prospective Evaluation Of Hypofractionated Stereotactic Body Radiotherapy For Low And Intermediate Risk Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00977860
• Other study ID #: HCC 09-031
• Status: Completed
• Phase: N/A
• Start date: October 7, 2010
• Est. completion date: July 8, 2022

Study information

• Verified date: April 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine, in both low-risk and intermediate-risk cohorts, the rates of acute and late grade 3 or higher gastrointestinal and genitourinary toxicity observed during a 24 month follow up and to estimate the rate of biochemical Disease-Free Survival, Phoenix and American Society for Therapeutic Radiology and Oncology definitions, at 2 years following hypofractionated stereotactic body radiation therapy for low and intermediate risk prostate cancer.

Description:

Radiosurgery should be ideal for treating prostate cancer because:

• targeting accuracy for static targets is excellent, with an error of about 1mm,

• it can adjust for intra-fractional organ motion, reducing the volume of the target PTV and therefore the dose to surrounding organs,

• by using over one-hundred non-conplanar beams, the dose gradient between the prostate and surrounding tissues may be superior to that achieved with conventional linear accelerators,

• the radiobiology of prostate cancer may favor large dose per fractions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: July 8, 2022
• Est. primary completion date: July 8, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically proven prostate adenocarcinoma

• Gleason score 2-7

• Biopsy within one year of date of registration

• Clinical stage T1b-T2b, N0-Nx, M0-Mx (AJCC 6th Edition)

• T-stage and N-stage determined by physical exam and available imaging studies (ultrasound, CT, and/or MRI)

• M-stage determined by physical exam, CT or MRI. Bone scan not required unless clinical findings suggest possible osseous metastases.

• PSA = 20 ng/dL

• Patients belonging in one of the following risk groups:

• Low: CS T1b-T2a and Gleason 2-6 and PSA = 10, or

• Intermediate: CS T2b and Gleason 2-6 and PSA = 10, or CS T1b-T2b, and Gleason 2-6 and PSA = 20 ng/dL, or Gleason 7 and PSA = 10 ng/dL

• Prostate volume: = 100 cc

• Determined using: volume = p/6 x length x height x width

• Measurement from CT or ultrasound =90 days prior to registration.

• ECOG performance status 0-1

• Completion of patient questionnaires:FACT-G questionnaire, AUA questionnaire, EPIC-26 questionnaire, SHIM questionnaire, Utilization of Sexual Medications/Devices questionnaire

• Consent signed.

Exclusion Criteria:

• Prior prostatectomy or cryotherapy of the prostate

• Prior radiotherapy to the prostate or lower pelvis

• Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.

• Chemotherapy for a malignancy in the last 5 years.

• History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years.

• Hormone ablation for two months prior to enrollment, or during treat

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Stereotactic Body Radiation Therapy
36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period

Locations

Country	Name	City	State
United States	UPMC Hillman Cancer Center - Shadyside Radiation Oncology	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Adam Olson

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Acute Grade 3 or Higher GI and GU Toxicities	Number of patients experiencing acute grade 3 or higher GI and GU toxicities. Acute toxicities are those occurring within 90 days of start of treatment, assessed using the NCI Common Toxicity Criteria (CTCAE) version 3.0.	Up to 90 days
Primary	Rate of Late Grade 3 or Higher GI and GU Toxicities	Number of patients experiencing late grade 3 or higher GI and GU toxicities. Late toxicities are those occurring after 90 days post start of treatment, assessed using the NCI Common Toxicity Criteria (CTCAE) version 3.0.	After 90 days post-treatment, up to 5 years per patient
Primary	Biochemical Disease-Free Survival Rate (bDFS)	Biochemical Disease-Free Survival (bDFS) as defined by Phoenix and ASTRO. Biochemical progression-free survival events were defined as PSA of = 0.4 ng/mL following postoperative radiotherapy, PSA > 2.0 ng/mL at any time, clinical progression, initiation of non-protocol hormone therapy, and death from any cause.	Up to 5 years
Secondary	Rate of Local Failure	Proportion of patients with 'local failure', which is defined as clinical evidence local recurrence. Clinical failure includes a palpable abnormality that has increased in size, failure of regression of a palpable abnormality, or redevelopment of a prostate abnormality after complete response, further confirmed by prostate biopsy.	Up to 5 years
Secondary	Rate of Distant Failure	Proportion of patients with 'distant failure' (includes regional failure) which is defined as documented clinically via bone scan, CT or other imaging study that shows metastatic disease (disease located distant from the prostate area).	Up to 5 years
Secondary	5-year Overall Survival (OS)	Percentage of patients that remained alive 5 years after start of study treatment. Deaths were from any cause.	At 5 years
Secondary	Quality of Life (QoL) - FACT-G - Prior to Therapy	The Functional Assessment of Cancer Therapy- General (FACT-G) is a self-administered 27-item questionnaire designed to measure four domains of HRQOL in cancer patients. It is comprised of physical (PWB), social (SWB), emotional (EWB), and functional (FWB) well-being subscales: (PWB; 7-items, score range 0-28), (SWB; 7-items, score range 0-28), (EWB; 6-items, score range 0-24), (FWB; 7-items, score range 0-28). The FACT-G generates an overall score of 0-108). All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much) and asks information regarding the patients last 7 days.	Prior to start of therapy
Secondary	Quality of Life (QoL) - FACT-G - At 24 Months	The Functional Assessment of Cancer Therapy- General (FACT-G) is a self-administered 27-item questionnaire designed to measure four domains of HRQOL in cancer patients. It is comprised of physical (PWB), social (SWB), emotional (EWB), and functional (FWB) well-being subscales: (PWB; 7-items, score range 0-28), (SWB; 7-items, score range 0-28), (EWB; 6-items, score range 0-24), (FWB; 7-items, score range 0-28). The FACT-G generates an overall score of 0-108). All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much) and asks information regarding the patients last 7 days.	At 24 months (post-start of therapy)