Single Fraction HDR Brachytherapy Plus Hypofractionated EBRT for Low-risk Prostate Cancer: Phase II Trial

Prostatic Neoplasms Clinical Trial

— AC-P01  

Official title:

Single Fraction High Dose Rate (HDR) Brachytherapy Plus Hypofractionated External Beam Radiotherapy (EBRT) for Low-risk Prostate Cancer: Phase II Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02283346
• Other study ID #: AC-P01
• Status: Not yet recruiting
• Phase: Phase 2
• First received: November 3, 2014
• Last updated: November 4, 2014
• Start date: November 2014
• Est. completion date: November 2017

Study information

• Verified date: November 2014
• Source: AC Camargo Cancer Center
• Contact: Lucas G Sapienza, MD
• Phone: +55(11)987612991
• Email: lucasgsapienza[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The hypofractionated external radiation (EBRT) is a technique that radiation dose delivery using higher daily fractions than those used routinely. In this way can cause more damage tumor, especially in tissues that have a slower proliferation rate, as in the case of prostate cancer. Furthermore, achieves a reduction in total treatment time and probably a lesser chance of development of collateral in tissues of high multiplication rate as the lining of the rectum and bladder effects.

With brachytherapy boost for high dose rate is achieved by administering a more intense dose on the tumor and lower the sound around the region to be treated tissues, improving the therapeutic window.

Treatment with retracted and fully ambulatory time, has potential benefit as early patient return to usual activities and optimizing the flow of patients who require treatment with radiotherapy. This prospective study aims to assess the results and the toxicity profile of this treatment regimen retracted.

Description:

OBJECTIVE The primary objective is to analyze the toxicity profile, via a phase II study of treatment of patients with low risk prostate cancer with the association of hypo fractionated EBRT and HDR brachytherapy boost.

It will also analyze the biochemical control and expense to the procedure.

STUDY DESIGN Prospective phase II study and not randomized. Patients with localized low-risk prostate cancer will be recruited to participate in protocol hypofractionated external beam radiotherapy followed by brachytherapy high dose rate.

INCLUSION CRITERIA

• Biopsy confirming adenocarcinoma of the prostate;

• Low risk prostate cancer: less than or equal T2a, and less than or equal to 10 ng PSA / ml stage and Gleason score less than or equal to 6

• Prostate volume less than or equal to 60cc.

EXCLUSION CRITERIA

• Patients under 18 or over 90 years;

• Adjuvant Hormone (any duration);

• Prior pelvic radiotherapy;

• Adjuvant Chemotherapy.

OUTCOMES

Primary outcomes:

Reduction of rectal acute morbidity (within three months of treatment) and late (after three months to twelve months from the last treatment recruited patient).

Reduction of acute urinary morbidity (within three months of treatment) and late (after three months to twelve months from the last treatment recruited patient).

The primary outcomes (toxicity) will be evaluated in patients who receive more than 90% of the intended dose protocol with crte and HDR brachytherapy.

(Scale used: CTCAE v4.03, Published online: May 28,2009 by the United States Department of Health and Human Services - NIH - attached).

Secondary outcomes:

Biochemical control (serial PSA measurements at intervals of three months in the first year, four months in the second year, six months of the third year onwards).

Cost-analysis procedure

STAGING

Performing the following tests:

1. Physical examination - rectal (TR)

2. transrectal US (TRUS)

3. pelvic CT

4. serum prostatic specific antigen (PSA) dosage

5. Bone Scan

ETHICAL ASPECTS The treatment regimen will be monitored for the possible emergence of excessive toxicity, considering that the same appearance in more than 25% of cases will be cause for termination of the protocol.

The study will begin after approval by the Research Ethics Committee (CEP) of the AC Camargo Cancer Center. Each patient will sign a term of informed consent (IC) prior to study entry. The term was written in accessible layman's language the patient, following the ethical recommendations. Patients may withdraw from the study at any time, without prejudice to the proposed treatment. We declare the confidentiality of personally identifiable patient, it is not possible to identify it during analysis and publication of data.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Biopsy confirming adenocarcinoma of the prostate

• Low-risk Prostate Cancer: less than or equal T2a stage + PSA less than or equal to 10 ng/ml stage + Gleason score less than or equal to 6

• Prostate volume than or equal to 60cc

Exclusion Criteria:

• Adjuvant Hormone

• Prior pelvic radiotherapy

• Adjuvant Chemotherapy

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Radiation:
• HDR brachytherapy + hypofractionated EBRT
Single Fraction High Dose Rate (HDR) Brachytherapy One fraction with 10-15 Gray (Gy) (depending on normal tissues constraints). + Hypofractionated External Beam Radiotherapy (EBRT) The treatment will be held with fractions 2.5 Gy per day, with a final dose between 25 and 50 Gy (depending on normal tissues constraints).

Locations

Country	Name	City	State
Brazil	AC Camargo Cancer Center	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
AC Camargo Cancer Center

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute and Late rectal and urinary morbidity	toxicity associated with the rectum and urinary tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)	12 weeks	No
Secondary	biochemical control	serum PSA increase (2.0ng/ml above the nadir)	3 years	No
Secondary	costs analysis of the treatment		one week after the treatment	No