Stereotactic Boost and Long-Term Androgen Deprivation for Adenocarcinoma of the Prostate

NCT ID: NCT02064036

Last Updated: 2022-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-06
• Study Completion Date: 2021-10-29

Brief Summary

We hypothesize that Stereotactic Body Radiotherapy Boost (SBRT) as a boost to the prostate following whole pelvic intensity modulated radiotherapy (IMRT) can be delivered effectively and safely in a population of men with unfavorable intermediate and high risk localized prostate cancer.

Our primary objective is to assess the feasibility and safety of a treatment strategy incorporating whole pelvic IMRT followed by an SBRT boost to the prostate with neoadjuvant, concurrent, and adjuvant androgen deprivation for a total of 28 months for men with unfavorable intermediate or high risk localized prostate cancer.

Detailed Description

The primary objective of this study is to assess the feasibility and safety of a treatment strategy incorporating whole pelvic IMRT followed by an SBRT boost to the prostate with neoadjuvant, concurrent, and adjuvant androgen deprivation for a total of 28 months for men with unfavorable intermediate or high risk localized prostate cancer.

The secondary objective is to assess biochemical control at 24 months following the experimental treatment strategy by the "Phoenix definition". Patients not meeting these prostate-specific antigen (PSA) criteria (Phoenix Definition) for failure who undergo salvage therapies (such as androgen deprivation therapy (ADT), radical prostatectomy or brachytherapy, or Cryosurgery) should also be declared as failures at the time a positive biopsy is obtained or salvage therapy is administered, whichever comes first.

Another secondary objective is to assess toxicity of the experimental treatment approach as scored by the Common Terminology Criteria for Adverse Events The third secondary objective is to assess prostate organ motion during hypofractionated radiotherapy. To assess motion of the prostate during the protracted delivery of hypofractionated radiotherapy as assessed by implanted electromagnetic transponder beacons.

Conditions

Adenocarcinoma of the Prostate

Study Design

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

Study Groups

Single

Neoadjuvant Androgen Blockade (Casodex) Followed by: Intensity Modulated Radiotherapy (IMRT)2 with Concurrent Androgen Blockade (Casodex and Leuprolide) to Whole Pelvis, Prostate, and Seminal VesiclesFollowed by: Stereotactic Radiosurgical Boost3 to the Prostate with Implanted Electromagnetic Transponder Beacon Intrafraction Guidance Followed by: Adjuvant Androgen Blockade (Casodex)

Group Type: EXPERIMENTAL

Stereotactic Radiosurgical Boost

Intervention Type: RADIATION

Intensity Modulated Radiotherapy (IMRT)2 with Concurrent Androgen Blockade to Whole Pelvis, Prostate, and Seminal Vesicles Followed by: Stereotactic Radiosurgical Boost3 to the Prostate with Implanted Electromagnetic Transponder Beacon Intrafraction Guidance

Casodex

Intervention Type: DRUG

Neoadjuvant Androgen Blockade before radiation therapy and Adjuvant Androgen Blockade after radiation therapy

Leuprolide

Intervention Type: DRUG

Neoadjuvant Androgen Blockade before radiation therapy and Adjuvant Androgen Blockade after radiation therapy

Interventions

Stereotactic Radiosurgical Boost

Intensity Modulated Radiotherapy (IMRT)2 with Concurrent Androgen Blockade to Whole Pelvis, Prostate, and Seminal Vesicles Followed by: Stereotactic Radiosurgical Boost3 to the Prostate with Implanted Electromagnetic Transponder Beacon Intrafraction Guidance

Intervention Type: RADIATION

Casodex

Neoadjuvant Androgen Blockade before radiation therapy and Adjuvant Androgen Blockade after radiation therapy

Intervention Type: DRUG

Leuprolide

Neoadjuvant Androgen Blockade before radiation therapy and Adjuvant Androgen Blockade after radiation therapy

Intervention Type: DRUG

Other Intervention Names

Intensity Modulated Radiotherapy (IMRT); Radiotherapy,; X-ray therapy; Irradiation; Bicalutamide; Goserelin

Eligibility Criteria

Inclusion Criteria

1. Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate to high risk for recurrence

2. History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registration.

3. Clinically negative lymph nodes as established by imaging (pelvic ± abdominal CT or MRI), (but not by nodal sampling, or dissection) within 90 days prior to registration.

4. Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 2.0 cm.

5. No evidence of bone metastases (M0) on bone scan within 90 days prior to registration.

6. Equivocal bone scan findings are allowed if plain films (or CT or MRI) are negative for metastasis.

7. Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 12 weeks (90 days) prior to registration.

8. Study entry PSA should not be obtained during the following time frames: (1) 10-day period following prostate biopsy; (2) following initiation of hormonal therapy; (3) within 30 days after discontinuation of finasteride; (4) within 90 days after discontinuation of dutasteride.

9. Zubrod Performance Status 0-2

10. Complete blood count (CBC)/differential obtained within 2 weeks (14 days) prior to registration on study, with adequate bone marrow function

11. Patient must be able to provide study specific informed consent prior to study entry.

Exclusion Criteria

1. Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 2 years.

2. Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer

3. Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy

4. Previous hormonal therapy

5. Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation is ≤ 60 days prior to the date of registration.

6. Use of finasteride within 30 days prior to registration

7. Use of dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration

8. Previous or concurrent cytotoxic chemotherapy for prostate cancer; note that prior chemotherapy for a different cancer is allowable. See Section 3.2.1.

9. Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields

10. Severe, active co-morbidity including heart issues, infection and liver problems

11. Patients who are sexually active and not willing/able to use medically acceptable forms of contraception

12. Prior allergic reaction to the hormones involved in this protocol

13. Patients status-post a negative lymph node dissection are not eligible

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Valicenti, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

UC Davis Sacramento Cancer Center Dept of Radiation Oncology

Sacramento, California, United States

Countries

United States

Other Identifiers

CCRO025

Identifier Type: OTHER

Identifier Source: secondary_id

421870

Identifier Type: -

Identifier Source: org_study_id