MRI-Guided Lattice Extreme Ablative Dose Radiotherapy For Prostate Cancer

NCT ID: NCT01411319

Last Updated: 2021-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-27
• Study Completion Date: 2020-03-02

Brief Summary

The hypotheses of this study are:

1. Delivery of single fraction Lattice Extreme Ablative Dose (LEAD) radiotherapy (RT) to the dominant tumor lesion(s) in the prostate as identified by multiparametric functional Magnetic Resonance Imaging is safe and feasible when given prior to standard prostate radiotherapy.

2. Biomarker expression levels differ in the functional MRI identified suspicious tumor regions and unsuspicious tumor regions. The investigators hypothesize that a significant source of variation in biomarker levels is due to tumor heterogeneity and that it is molecular abnormalities in the dominant tumor areas that are angiogenic and determine outcome.

Conditions

Prostate Cancer; Prostate Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LEAD Radiation Therapy

Participants in this group will receive the LEAD Radiation Therapy on Day 1 followed by 38 daily standard IMRT beginning Day 2.

Group Type: EXPERIMENTAL

Lattice Extreme Ablative Dose Radiation Therapy

Intervention Type: RADIATION

12 - 14 Gy dose pipes in 1 fraction to the multiparametric MRI defined gross tumor volumes (GTV) on Day 1.

Standard IMRT

Intervention Type: RADIATION

76 Gy in 38 fractions (2 Gy daily) of Standard Intensity-modulated radiation therapy (IMRT) starting on Day 2 for 7.5 weeks.

Interventions

Lattice Extreme Ablative Dose Radiation Therapy

12 - 14 Gy dose pipes in 1 fraction to the multiparametric MRI defined gross tumor volumes (GTV) on Day 1.

Intervention Type: RADIATION

Standard IMRT

76 Gy in 38 fractions (2 Gy daily) of Standard Intensity-modulated radiation therapy (IMRT) starting on Day 2 for 7.5 weeks.

Intervention Type: RADIATION

Other Intervention Names

LEAD RT; IMRT

Eligibility Criteria

Inclusion Criteria

1. Biopsy confirmed adenocarcinoma of the prostate.

2. T1-T3a disease based on digital rectal exam (DRE).

• T3a disease based on MRI is acceptable (no evidence of frank (clear cut) seminal vesicle (SV) involvement or invasion of bladder or rectum).

3. Gleason score 6-10.

4. Patients with Gleason score ≥8 must be offered long term androgen deprivation therapy (ADT) and refuse such treatment because only 4-6 months (+/- 2 months) (short term ADT) is permitted (not required) on this protocol. The ADT is recommended to begin after fiducial marker placement; however, ADT is permitted to have been started up to two months prior to the signing of consent. All patients in this protocol may (not required) be treated with 4-6 months (+/- 2 months) of ADT, at the discretion of the treating physician.

• Gleason ≥ 8 must have < 40% of the tissue involved with Gleason 8 in the biopsy specimen.

5. Prostate-specific antigen (PSA) ≤ 30 ng/mL within 3 months of enrollment. If PSA was above 30 and dropped to ≤ 30 with antibiotics, this is acceptable for enrollment.

6. No previous pelvic radiotherapy.

7. No previous history of radical/total prostatectomy (suprapubic prostatectomy is acceptable).

8. No 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 ≥ 5 years then the patient is eligible.

9. Identifiable multiparametric-MRI tumor lesion or lesions, that total in volume < 33% of the prostate

• Multiparametric MRI of prostate and pelvis is required prior to protocol consideration.
• If contrast not given, the point dose on the apparent diffusion coefficient (ADC) map should be < 1000.

10. Ability to understand and the willingness to sign a written informed consent document.

11. Zubrod performance status < 2.

12. Willingness to fill out quality of life forms.

13. Bone scan negative if PSA > 15 ng/mL or Gleason ≥ 8 disease. A questionable bone scan is acceptable if other imaging tests are negative for metastasis.

14. Serum testosterone is within 40% of normal assay limits (e.g., x=0.4*lower assay limit and x=.04*upper assay limit + upper assay limit), and taken within 4 months of enrollment. Patients who have been started on ADT prior to signing consent are not required to have a serum testosterone at this level prior to signing consent; but, a serum testosterone prior to fiducial marker placement is recommended.

15. Serum liver function tests (LFT) are taken within 3 months of enrollment.

16. Complete blood counts are taken within 3 months of enrollment.

17. Age ≥ 35 and ≤ 85 years.

Exclusion Criteria

1. > T3a disease on digital rectal exam or >T3a disease clearly identified by MRI.

2. Gleason score < 6.

3. ≥ 40% Gleason 8-10 tumor, over the total tissue including other tumor and normal tissue. For example: (Gleason 8-10 tumor length/other biopsy tissue length)*100 = ≥ 40%.

4. Androgen deprivation therapy longer than 8 months. Androgen deprivation timing is for the Luteinizing hormone-releasing hormone (LHRH) agonist portion only and not when anti-androgen is started beforehand with the purpose of counteracting the surge in testosterone from the LHRH agonist - PSA > 30 ng/mL within 3 months of enrollment.

5. PSA > 30 ng/mL within 3 months of enrollment

6. Unable to obtain a 1.5T or 3.0T multiparametric MRI of the pelvis and prostate with contrast.

7. Unidentifiable multiparametric MRI tumor lesion.

8. Identifiable multiparametric-MRI tumor lesions, that total in volume ≥ 33% of the prostate.

9. Previous pelvic radiotherapy.

10. Previous history of radical prostatectomy.

11. Concurrent, active malignancy, which is not nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for < 5 years then the patient is not eligible.

12. Zubrod performance status ≥ 2.

13. Inability to understand or unwilling to sign a written informed consent document

14. Unwilling to fill out quality of life/psychosocial forms.

15. Bone scan is positive and other imaging tests confirm a suspicion of metastasis from prostate cancer.

16. Serum testosterone is not within 40% of normal assay limits taken within 4 months of enrollment (only applicable to patients not started on ADT prior to signing consent).

17. Serum liver function tests (LFTs) are not taken within 3 months of enrollment.

18. Complete blood counts are not taken within 3 months of enrollment.

19. Age < 35 and > 85 years.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Alan Pollack, MD, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alan Pollack, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

References

Pollack A, Chinea FM, Bossart E, Kwon D, Abramowitz MC, Lynne C, Jorda M, Marples B, Patel VN, Wu X, Reis I, Studenski MT, Casillas J, Stoyanova R. Phase I Trial of MRI-Guided Prostate Cancer Lattice Extreme Ablative Dose (LEAD) Boost Radiation Therapy. Int J Radiat Oncol Biol Phys. 2020 Jun 1;107(2):305-315. doi: 10.1016/j.ijrobp.2020.01.052. Epub 2020 Feb 19.

Reference Type: RESULT

PMID: 32084522 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R21CA153826

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20100389

Identifier Type: -

Identifier Source: org_study_id