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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-03

Study Completion Date

2021-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Highly Conformal, Hypofractionated, Focally Dose Escalated Post-Prostatectomy Radiotherapy

NCT03388619

Cancer Of Prostate Prostate Neoplasms Prostate Cancer +2 more

COMPLETED PHASE1

Conventional or Hypofractionated Radiation Therapy in Treating Patients With Prostate Cancer

NCT03987386

Stage I Prostate Cancer AJCC v8 Stage II Prostate Cancer AJCC v8 Stage III Prostate Cancer AJCC v8 +1 more

ACTIVE_NOT_RECRUITING PHASE3

Short-course Hypofractionated Radiotherapy for Localized Prostate Cancer

NCT00126165

Prostate Cancer

COMPLETED PHASE1/PHASE2

Pelvic Nodes Ultra-Hypo vs Conventionally Fractionated IMRT With HDR Boost in Prostate Cancer.

NCT05820633

Prostate Cancer Node; Prostate Radiotherapy Side Effect

SUSPENDED NA

Hypofractionated Radiotherapy (55 Gy/16 Fractions/4 Weeks) for Localized Prostate Cancer

NCT00129025

Prostate Cancer

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients in this study will be randomly picked (as in the toss of a coin) to be in one of two treatment groups. There is an equal chance of being in either group.

Patients in Group 1 will be treated with intensity modulated radiotherapy (IMRT). These patients will receive 42 treatments, 5 days per week, over 8.5 weeks. This method has become the standard treatment at M.D. Anderson Cancer Center.

Patients in Group 2 will also be treated with IMRT. However, these patients will only receive 30 treatments, 5 days per week, over 6 weeks. The dose per day for Group 2 patients is higher than for Group 1 and has the possibility of killing more tumor cells.

Each external beam treatment requires about 10-20 minutes. However, patients can expect to spend 20 - 30 minutes on the treatment table because imaging measurements of prostate position will be done before each treatment. The total time in the radiation department each treatment day will be about an hour.

After the radiotherapy is completed, patients will have a PSA blood test every 3 months for 2 years, then every 6 months for Years 3 - 5, then annually. They will be examined every 6 months during the first 2 years beginning 3 months after the completion of treatment, then annually. A needle biopsy of the prostate will be performed if these tests suggest recurrence.

This is an investigational study. 225 patients will take part in this study. This study will take place at M. D. Anderson and possibly some affiliated hospitals.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intensity Modulated Radiotherapy (IMRT)

A total dose of 75.6 Gy will be delivered in 42 fractions to the planning target volume (PTV).

Group Type ACTIVE_COMPARATOR

Conventional Fractionated Intensity Modulated Radiotherapy

Intervention Type RADIATION

A total dose of 75.6 Gy will be delivered in 42 fractions to the planning target volume (PTV).

Hypofractionated Intensity Modulated Radiotherapy (HIMRT)

A total dose of 72 Gy will be delivered in 30 fractions to the PTV.

Group Type EXPERIMENTAL

Hypofractionated Intensity Modulated Radiotherapy

Intervention Type RADIATION

A total dose of 72 Gy will be delivered in 30 fractions to the PTV.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Conventional Fractionated Intensity Modulated Radiotherapy

A total dose of 75.6 Gy will be delivered in 42 fractions to the planning target volume (PTV).

Intervention Type RADIATION

Hypofractionated Intensity Modulated Radiotherapy

A total dose of 72 Gy will be delivered in 30 fractions to the PTV.

Intervention Type RADIATION

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

IMRT HIMRT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Eligible Sex

MALE

Accepts Healthy Volunteers

No