Phase II Trial of SBRT + or - IMRT in T… | Clinical Trial

Key information

Conditions

Prostate Adenocarcinoma

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

21st Century Oncology, Fort Myers, Florida, United States

About this study

Patients with locally confined prostate adenocarcinoma (clinical stage T1c - T2bN0M0, Gleason score 7, PSA 20 ng/ml) are assigned to one of two treatment arms. Low risk patients (T1c-T2a and PSA <10 ng/ml and Gleason Score 6 or less) will receive 5 fractions of 8.0 Gy for a total of 40 Gy. Intermediate risk patients (T2b or PSA >10 ng/ml orGleason Score 7) will receive 1.8 Gy of IMRT for 25 fractions over 5 weeks for a total of 45 Gy. They will then receive a boost consisting of 4, 5.5 Gy fractions after IMRT for a total of 22 Gy. All patients will be assessed for toxicity at periodic time points following completion of treatment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Histologically determined adenocarcinoma is required.
All other histologies are excluded.
Tissue for diagnosis must be obtained by transrectal ultrasound biopsy.
Gleason scoring classification of the biopsy specimen is required and must be greater than or equal to 7.
2002 AJCC clinical cancer stage as determined by either urologist or radiation oncologist must be T1c - T2b, N0, M0.
N0 stage may be assigned following either negative imaging or negative pathologic assessment.
Prostate volume as assessed by TRUS must be less than 60 cc. 3.1.5.
PSA must be less than 20 ng/ml. ,
Age ≥ 18,
IPSS voiding symptoms score must be less than 18,
Study consent form must be signed by the patient.

Exclusion criteria

Gleason score of 8 - 10,
Clinical stage T3 - T4,
Age ≤ 18,
Any evidence of nodal (N1) or distant (M1) disease,
Prostate volume as assessed by TRUS > 60 cc,
PSA > 20 ng/ml,
IPSS voiding symptoms score > 18,
Prior TURP,
Prior pelvic radiotherapy or chemotherapy,
Prior prostatectomy,
Prior cancer other than basal cell or squamous cell skin carcinoma unless free of disease for > 5 years,
Current medical or psychiatric illness that may interfere with treatment completion and followup,
Hip prosthesis,
Unable or unwilling to give informed consent

Treatment and study plan

SBRT

Radiation

8.0 Gy per fraction for 5 fractions for a total of 40 Gy

Other names: SBRT only

Primary outcomes

To estimate the rate of chronic grade 3 - 5 genitourinary (GU) and gastrointestinal (GI) toxicity of SBRT either as a boost following conventionally fractionated IMRT or as a monoradiotherapy

Time frame: Periodical (baseline, during treatment, and at 1 month, 3 months, 6 months, 9 months, and 12 months post treatment. For the second and third years after therapy completion, follow-up visits will be every 6 months. Then annually for ____ years.

At baseline, during treatment, and at 1 month, 3 months, 6 months, 9 months, and 12 months post treatment. For the second and third years after therapy completion, follow-up visits will be every 6 months. After the third year after therapy completion, follow-up visits will be annually for life, up to 10 years.

Sponsors and collaborators

Lead sponsor

GenesisCare USA

Other

Registry information

Official study title

A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) With or Without Intensity Modulated Radiation Therapy (IMRT) in the Treatment of Patients With Clinically Confined Prostate Adenocarcinoma

Important dates

Study start: 2006
Primary completion: 2019
Study completion: 2019
First posted: Jan 16, 2015
Registry last updated: Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed