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Multi-institutional registry for prostate cancer radiosurgery: a prospective observational clinical trial.

Freeman D, Dickerson G, Perman M - Front Oncol (2015)

Bottom Line: One patient developed Grade 3 gastrointestinal toxicity (rectal bleeding).Erectile function was preserved in 80% of men <70 years old.Overall compliance with data entry was 64%.

View Article: PubMed Central - PubMed

Affiliation: Naples Radiation Oncology , Naples, FL , USA.

ABSTRACT

Objective: To report on the design, methodology, and early outcome results of a multi-institutional registry study of prostate cancer radiosurgery.

Methods: The Registry for Prostate Cancer Radiosurgery (RPCR) was established in 2010 to further evaluate the efficacy and toxicity of prostate radiosurgery (SBRT) for the treatment of clinically localized prostate cancer. Men with prostate cancer were asked to voluntarily participate in the registry. Demographic, baseline medical, and treatment-related data were collected and stored electronically in a Health Insurance Portability and Accountability Act-compliant database, maintained by Advertek, Inc. Enrolled men were asked to complete short, multiple choice questionnaires regarding their bowel, bladder, and sexual function. Patient-reported outcome forms were collected at baseline and at regular intervals (every 3-6 months) following treatment. Serial prostate-specific antigen measurements were obtained at each visit and included in the collected data.

Results: From July 2010 to July 2013, nearly 2000 men from 45 participating sites were enrolled in the registry. The majority (86%) received radiosurgery as monotherapy. At 2 years follow-up, biochemical disease-free survival was 92%. No Grade 3 late urinary toxicity was reported. One patient developed Grade 3 gastrointestinal toxicity (rectal bleeding). Erectile function was preserved in 80% of men <70 years old. Overall compliance with data entry was 64%.

Conclusion: Stereotactic radiosurgery is an alternative option to conventional radiotherapy for the treatment of organ-confined prostate cancer. The RPCR represents the collective experience of multiple institutions, including community-based cancer centers, with outcome results in keeping with published, prospective trials of prostate SBRT.

No MeSH data available.


Related in: MedlinePlus

Actuarial biochemical disease-free survival, stratified by risk group.
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Figure 2: Actuarial biochemical disease-free survival, stratified by risk group.

Mentions: The 2-year biochemical disease-free survival (bDFS) for the entire patient cohort was 92%. Stratified by risk group, 2-year bDFS was 99, 97, 85, and 87% for low risk, intermediate risk (Gleason 3 + 4), intermediate risk (Gleason 4 + 3) and high risk patients, respectively (p = 0.03) (Figure 2). PSA levels declined sharply in the first 6 months following radiosurgery, with a continued downward trend in PSA levels between 18 months and 2 years following treatment (Figure 3).


Multi-institutional registry for prostate cancer radiosurgery: a prospective observational clinical trial.

Freeman D, Dickerson G, Perman M - Front Oncol (2015)

Actuarial biochemical disease-free survival, stratified by risk group.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4302811&req=5

Figure 2: Actuarial biochemical disease-free survival, stratified by risk group.
Mentions: The 2-year biochemical disease-free survival (bDFS) for the entire patient cohort was 92%. Stratified by risk group, 2-year bDFS was 99, 97, 85, and 87% for low risk, intermediate risk (Gleason 3 + 4), intermediate risk (Gleason 4 + 3) and high risk patients, respectively (p = 0.03) (Figure 2). PSA levels declined sharply in the first 6 months following radiosurgery, with a continued downward trend in PSA levels between 18 months and 2 years following treatment (Figure 3).

Bottom Line: One patient developed Grade 3 gastrointestinal toxicity (rectal bleeding).Erectile function was preserved in 80% of men <70 years old.Overall compliance with data entry was 64%.

View Article: PubMed Central - PubMed

Affiliation: Naples Radiation Oncology , Naples, FL , USA.

ABSTRACT

Objective: To report on the design, methodology, and early outcome results of a multi-institutional registry study of prostate cancer radiosurgery.

Methods: The Registry for Prostate Cancer Radiosurgery (RPCR) was established in 2010 to further evaluate the efficacy and toxicity of prostate radiosurgery (SBRT) for the treatment of clinically localized prostate cancer. Men with prostate cancer were asked to voluntarily participate in the registry. Demographic, baseline medical, and treatment-related data were collected and stored electronically in a Health Insurance Portability and Accountability Act-compliant database, maintained by Advertek, Inc. Enrolled men were asked to complete short, multiple choice questionnaires regarding their bowel, bladder, and sexual function. Patient-reported outcome forms were collected at baseline and at regular intervals (every 3-6 months) following treatment. Serial prostate-specific antigen measurements were obtained at each visit and included in the collected data.

Results: From July 2010 to July 2013, nearly 2000 men from 45 participating sites were enrolled in the registry. The majority (86%) received radiosurgery as monotherapy. At 2 years follow-up, biochemical disease-free survival was 92%. No Grade 3 late urinary toxicity was reported. One patient developed Grade 3 gastrointestinal toxicity (rectal bleeding). Erectile function was preserved in 80% of men <70 years old. Overall compliance with data entry was 64%.

Conclusion: Stereotactic radiosurgery is an alternative option to conventional radiotherapy for the treatment of organ-confined prostate cancer. The RPCR represents the collective experience of multiple institutions, including community-based cancer centers, with outcome results in keeping with published, prospective trials of prostate SBRT.

No MeSH data available.


Related in: MedlinePlus