Phase II Trial of SBRT + or - IMRT in Treatment of Patients With Clinically Confined Prostate Adenocarcinoma

NCT02339948 | Completed

• 1 other identifier: 21C-2006-01
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Prostate Adenocarcinoma

Keywords

Locally confined

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  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.

Study Arms (2)

SBRT only

ACTIVE COMPARATOR

Patients assigned to this arm receive 8.0 Gy per fraction for 5 fractions for a total of 40 Gy

Radiation: SBRT

IMRT plus SBRT Boost

ACTIVE COMPARATOR

Patients assigned to this arm receive 1.8 Gy per fraction for 25 fractions over 5 weeks for a total of 45.0 Gy followed by an SBRT boost of 5.5 Gy per fraction for 4 fractions after IMRT for a total of 22.0 Gy

Radiation: SBRT

Interventions

SBRT RADIATION

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

Also known as: SBRT only

IMRT plus SBRT Boost; SBRT only

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GenesisCare USA: lead

Study Sites (4)

21st Century Oncology

Fort Myers, Florida, 33907, United States

Location

21st Century Oncology

Plantation, Florida, 33324, United States

Location

21st Century Oncology

Farmington Hills, Michigan, 48334, United States

Location

Century Oncology

Myrtle Beach, South Carolina, 29577, United States

Location

Study Officials

• Constantine Mantz, MD

  GenesisCare USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 16, 2015
• Study Start: June 1, 2006
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

US (4)