Phase I/II Hypofractionated Radiotherapy for Prostate Cancer

University of Wisconsin (UW)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Prostate Cancer

Treatments: Radiation: Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00214097

A533300 (Other Identifier)

2002-322 (Other Identifier)

SMPH/HUMAN ONCOLOGY (Other Identifier)

NCI (P01 CA88960)

RO02803

Details and patient eligibility

About

The purpose of this study is to examine the clinical feasibility of using Intensity-modulated radiation therapy (IMRT) combined with daily pretreatment prostate localization to deliver increasingly hypofractionated treatment courses. Progressively larger fraction sizes will be delivered in a phase I design based on both acute and long-term tolerances to the treatment. The dose-per-fraction escalation design utilizes schemas that maintain an isoeffective dose for late effects, while predicting that tumor control will actually improve. The delivery of fewer, larger fractions of radiation, if proven effective and safe, would result in significant cost saving and more efficient use of resources. Phase II will commence with Maximum Tolerated Dose (MTD) finding with up to 200 additional patients being enrolled during this phase of the study.

Enrollment: 347 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Histologically proven adenocarcinoma of the prostate.

• Stage ≤ T2b disease, as defined by 1997 American Joint Committee on Cancer (AJCC) classification
• Predicted risk of lymph node involvement (by standard nomograms) of 15% or less (24), OR histologically negative pelvic nodes
• Gleason score ≤ 7
• No evidence of distant metastasis
• Age 18+
• Informed consent signed in accordance with institutional protocol
• Pretreatment evaluations must be completed as specified in Section 7.0.
• ECOG performance status 0-1
• No previous or concurrent cancers, other than localized basal cell or squamous cell skin carcinoma, unless continually disease free for at least 5 years
• No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
• Gonadotropin-releasing hormone agonist (GnRH-a) use permitted (maximum of 6 months duration). Anti-androgen therapy permitted concurrently with GnRH-a.
• No previous or concurrent cytotoxic chemotherapy
• No radical surgery or cryosurgery for prostate cancer
• The absence of any co-morbid medical condition which would constitute a contraindication for radical radiotherapy
• The absence of serious concurrent illness of psychological, familial, sociological, geographical or other concomitant conditions which do not permit adequate follow-up and compliance with the study protocol.
• No current use of anticoagulation therapy, other than aspirin.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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347 participants in 3 patient groups

Level 1

Experimental group

Description:

64.7 Gy/22 fractions of 2.94 Gy

Treatment:

Radiation: Radiotherapy

Level 2

Experimental group

Description:

58.08 Gy/16 fractions of 3.63 Gy

Treatment:

Radiation: Radiotherapy

Level 3

Experimental group

Description:

51.6 Gy/12 fractions of 4.3 Gy

Treatment:

Radiation: Radiotherapy