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

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.

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.

Study Overview

• Status: Completed
• Conditions: Adenocarcinoma of the Prostate
• Intervention / Treatment: Radiation: Stereotactic Radiosurgical Boost; Drug: Casodex; Drug: Leuprolide

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Sacramento Cancer Center Dept of Radiation Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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)

Radiation: 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; Other Names: Irradiation; Intensity Modulated Radiotherapy (IMRT); Radiotherapy,; X-ray therapy; Drug: Casodex; Neoadjuvant Androgen Blockade before radiation therapy and Adjuvant Androgen Blockade after radiation therapy; Other Names: Bicalutamide; Drug: Leuprolide; Neoadjuvant Androgen Blockade before radiation therapy and Adjuvant Androgen Blockade after radiation therapy; Other Names: Goserelin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Weekly during radiation treatment; every three months during hormone therapy; every six months for 3 yrs after hormone therapy

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Richard Valicenti, MD, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2013
• Primary Completion (Actual): December 3, 2020
• Study Completion (Actual): October 29, 2021

Study Registration Dates

• First Submitted: January 22, 2014
• First Submitted That Met QC Criteria: February 14, 2014
• First Posted (Estimate): February 17, 2014

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 16, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Prostate Cancer; Radiotherapy; Androgen Deprivation
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Adenocarcinoma; Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Androgen Antagonists; Leuprolide; Goserelin; Bicalutamide
• Other Study ID Numbers: 421870; CCRO025 (Other Identifier: UC Davis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No