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Stereotactic Boost and Long-Term Androgen Deprivation for Adenocarcinoma of the Prostate (CCRO025)

Primary Purpose

Adenocarcinoma of the Prostate

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Stereotactic Radiosurgical Boost

Casodex

Leuprolide

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Prostate focused on measuring Prostate Cancer, Radiotherapy, Androgen Deprivation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate to high risk for recurrence
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.
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.
Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 2.0 cm.
No evidence of bone metastases (M0) on bone scan within 90 days prior to registration.
Equivocal bone scan findings are allowed if plain films (or CT or MRI) are negative for metastasis.
Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 12 weeks (90 days) prior to registration.
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.
Zubrod Performance Status 0-2
Complete blood count (CBC)/differential obtained within 2 weeks (14 days) prior to registration on study, with adequate bone marrow function
Patient must be able to provide study specific informed consent prior to study entry.

Exclusion Criteria:

Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 2 years.
Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
Previous hormonal therapy
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.
Use of finasteride within 30 days prior to registration
Use of dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration
Previous or concurrent cytotoxic chemotherapy for prostate cancer; note that prior chemotherapy for a different cancer is allowable. See Section 3.2.1.
Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields
Severe, active co-morbidity including heart issues, infection and liver problems
Patients who are sexually active and not willing/able to use medically acceptable forms of contraception
Prior allergic reaction to the hormones involved in this protocol
Patients status-post a negative lymph node dissection are not eligible

Sites / Locations

UC Davis Sacramento Cancer Center Dept of Radiation Oncology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single

Arm Description

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)

Outcomes

Primary Outcome Measures

Tumor Assessment

Tumors will be assessed using the American Joint Committee on Cancer (AJCC) Staging System, 7th Edition. This system consists of the following subscales: the extent of the primary tumor (T category), whether the cancer has spread to nearby lymph nodes (N category), the absence or presence of distant metastasis (M category), the PSA level at the time of diagnosis, and the Gleason score, based on the prostate biopsy (or surgery).

Secondary Outcome Measures

Zubrod Performance Scale

This is a scale used to evaluate the patient's performance status is an attempt to quantify cancer patients' general well-being and activities of daily life.

Full Information

NCT ID

NCT02064036

First Posted

January 22, 2014

Last Updated

October 16, 2022

Sponsor

University of California, Davis

1. Study Identification

Unique Protocol Identification Number

NCT02064036

Brief Title

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

Acronym

CCRO025

Official Title

Whole-Pelvic Radiotherapy With a Stereotactic Body Radiotherapy Boost and Long-Term Androgen Deprivation for Unfavorable-Intermediate and High Risk Localized Adenocarcinoma of the Prostate.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

June 6, 2013 (Actual)

Primary Completion Date

December 3, 2020 (Actual)

Study Completion Date

October 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, Davis

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenocarcinoma of the Prostate

Keywords

Prostate Cancer, Radiotherapy, Androgen Deprivation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Radiosurgical Boost

Other Intervention Name(s)

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

Intervention Description

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

Drug

Intervention Name(s)

Casodex

Other Intervention Name(s)

Bicalutamide

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Leuprolide

Other Intervention Name(s)

Goserelin

Intervention Description

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

Primary Outcome Measure Information:

Title

Tumor Assessment

Description

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Zubrod Performance Scale

Description

This is a scale used to evaluate the patient's performance status is an attempt to quantify cancer patients' general well-being and activities of daily life.

Time Frame

Weekly during radiation treatment; every three months during hormone therapy; every six months for 3 yrs after hormone therapy

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate to high risk for recurrence 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. 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. Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 2.0 cm. No evidence of bone metastases (M0) on bone scan within 90 days prior to registration. Equivocal bone scan findings are allowed if plain films (or CT or MRI) are negative for metastasis. Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 12 weeks (90 days) prior to registration. 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. Zubrod Performance Status 0-2 Complete blood count (CBC)/differential obtained within 2 weeks (14 days) prior to registration on study, with adequate bone marrow function Patient must be able to provide study specific informed consent prior to study entry. Exclusion Criteria: Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 2 years. Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy Previous hormonal therapy 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. Use of finasteride within 30 days prior to registration Use of dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration Previous or concurrent cytotoxic chemotherapy for prostate cancer; note that prior chemotherapy for a different cancer is allowable. See Section 3.2.1. Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields Severe, active co-morbidity including heart issues, infection and liver problems Patients who are sexually active and not willing/able to use medically acceptable forms of contraception Prior allergic reaction to the hormones involved in this protocol Patients status-post a negative lymph node dissection are not eligible

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Valicenti, MD

Organizational Affiliation

University of California, Davis

Official's Role

Principal Investigator

Facility Information:

Facility Name

UC Davis Sacramento Cancer Center Dept of Radiation Oncology

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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