Clinical trial · Interventional

A Phase III Intensity Radiotherapy Dose Escalation for Prostate Cancer Using Hypofractionation

NCT00667888CI-TRIAL-00049582unknownPhase 3Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The goal of this clinical research study is to compare using external beam radiotherapy with intensity modulated beams for fewer days at a higher dose per day to the same type of therapy for more days at a lower dose per day in the treatment of prostate cancer. The safety of these treatments will also be studied and compared.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Prostate Cancer	Malignant Prostate Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Conventional Fractionated Intensity Modulated Radiotherapy	Radiation	—	UNRESOLVED
Hypofractionated Intensity Modulated Radiotherapy	Radiation	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
Intensity Modulated Radiotherapy (IMRT)
description
A total dose of 75.6 Gy will be delivered in 42 fractions to the planning target volume (PTV).
interventionNames
1. Radiation: Conventional Fractionated Intensity Modulated Radiotherapy
type
EXPERIMENTAL
label
Hypofractionated Intensity Modulated Radiotherapy (HIMRT)
description
A total dose of 72 Gy will be delivered in 30 fractions to the PTV.
interventionNames
1. Radiation: Hypofractionated Intensity Modulated Radiotherapy

Primary outcomes (1)

measure
Conventional Radiotherapy (CIMRT) Versus Hypofractionated Radiotherapy (HIMRT)

Eligibility

Eligibility (as posted)

Sex: Male

Show eligibility criteria text

Inclusion Criteria:

1. Biopsy proof of adenocarcinoma of the prostate.
2. Bone scan (If PSA \>10 ng/ml or T3 disease) within 3 months of starting androgen ablation or signing protocol consent if no androgen ablation.
3. CT-scan of pelvis (If Stage T3 disease) within 3 months of starting androgen ablation or signing protocol consent if no androgen ablation.
4. Suitable medical condition; Zubrod \<2.
5. Pretreatment PSA \</=20 ng/ml. If PSA \<4, must have Gleason greater than or equal to 7 and/or Stage T2b-T2c. PSA within 30 days of signing protocol consent. If neoadjuvant androgen ablation has been given, then the preandrogen ablation PSA should be used for stratification.
6. Clinical (palpable) Stage T1b - T3b disease (1992 AJCC staging system).
7. While a transrectal ultrasound will be obtained before treatment, the staging will not be based on these findings. If palpable T3 disease is present, then must have Gleason score \<8 and pretreatment PSA less than or equal to 10 ng/ml
8. Gleason score \<10.
9. If Gleason score 8 or 9, then must have stage T1/T2 disease and pretreatment PSA less than or equal to 10 ng/ml.
10. The patient must be able to understand the protocol and adhere to follow-up at 6-month intervals for the first 2 years and at yearly intervals thereafter.
11. Informed consent must be given.
12. Patients randomized to Arm 1 may also participate in protocol 2004-0428.

Exclusion Criteria:

1. Prior pelvic radiotherapy.
2. Greater than 4 months of prior hormone ablation therapy.
3. Prior or planned radical prostate surgery.
4. Clinical, radiographic or pathologic evidence of nodal or distant metastatic disease.
5. Concurrent, active malignancy, other than nonmetastatic skin cancer or early stage -chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for greater than or equal to 5 yr then the patient is eligible.
6. Zubrod status greater than or equal to 2.
7. Pretreatment PSA \>20 ng/ml.
8. Gleason score of 10.
9. Palpable stage T3c (seminal vesicle involvement) or T4 disease.

References

Publications (2)

DERIVEDHassanzadeh C, Kuban D, Pasyar S, Bassett R, Troncoso P, Ansari M, Schlembach P, McGuire S, Nguyen Q, Frank S, Mok H, Mohamad O, Park R, Tang C, Du W, Kudchadker R, Choi S, Hoffman K. Hypofractionated, Dose-Escalated Radiation Versus Conventionally Fractionated Radiation for Localized Prostate Cancer: Long-Term Update of a Phase III, Prospective, Randomized Controlled Trial. J Clin Oncol. 2025 Jun 20;43(18):2044-2048. doi: 10.1200/JCO-24-02057. Epub 2025 May 14. PMID 40367400
DERIVEDKim S, Kong JH, Lee Y, Lee JY, Kang TW, Kong TH, Kim MH, You SH. Dose-escalated radiotherapy for clinically localized and locally advanced prostate cancer. Cochrane Database Syst Rev. 2023 Mar 8;3(3):CD012817. doi: 10.1002/14651858.CD012817.pub2. PMID 36884035

Registry

Dates and enrollment

Start: Jan 3, 2001
Primary completion: Oct 12, 2015
Completion: Oct 1, 2021
First posted: Apr 28, 2008
Last update posted: Jan 25, 2021
Results first posted: Jan 25, 2021
Enrollment: 225 (actual)
Lead sponsor: M.D. Anderson Cancer Center OTHER
Keywords: Prostate Cancer, Radiation, Radiotherapy, Intensity Modulated Radiotherapy, IMRT, Hypofractionated Intensity Modulated Radiotherapy, HIMRT

Data updated 22 days agoSource updated Jan 25, 2021source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
United States	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.