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

Primary Purpose

Cancer Of Prostate, Prostate Neoplasms, Prostate Cancer

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Dose to prostate bed with integrated boost

Dose to prostate bed irradiation only

About this trial

This is an interventional treatment trial for Cancer Of Prostate focused on measuring Rising PSA, No evidence of metastatic disease, Entire Prostate Bed, Quality of Life, Irradiation

Eligibility Criteria

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

INCLUSION CRITERIA:
Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate.
Indications for post-prostatectomy radiation exist:
- Disease progression (detectable PSA on two measurements obtained at least one month apart) or
- indications for adjuvant radiation exist (if undetectable PSA): pathologic T3, T4, N+ disease or positive margins (within 1 year of prostatectomy).
Age greater than or equal to 18 years.
ECOG performance status less than or equal to 1 (Karnofsky greater than or equal to 60)
Ability of subject to understand and the willingness to sign a written informed consent document.
Radiation is teratogenic; thus, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and up to 120 days after the last radiation. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately.
HIV positive patients are included if CD4+ T-cell count > 200 cells/uL; on stable antiretroviral therapy for > 1 year with HIV viral load <200 copies/mL, and no history of opportunistic infections in > 1 year.

EXCLUSION CRIETERIA:

Patients who are receiving any other investigational agents concurrently.
Documented metastases of prostate cancer outside of the pelvis (pelvic lymph nodes are allowed only if within the prostate bed region).
History of radiation that would overlap with the intended treatment to the prostate bed.
Known contraindications to radiation such as inflammatory bowel disease, active systemic lupus or scleroderma, or radiation hypersensitivity syndrome (Ataxia Telangiectasia or Fanconi s Anemia)
Subjects with any coexisting medical or psychiatric condition which, in the opinion of the Investigator likely to interfere with study procedures and/or results.
Medically indicated use of known radiosensitizing drugs (such as protease inhibitors)

Sites / Locations

National Institutes of Health Clinical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

1/Prostate bed with integrated boost

2/Prostate bed irradiation only

Arm Description

Dose to prostate bed with integrated boost

Dose to prostate bed irradiation only

Outcomes

Primary Outcome Measures

Define the maximum tolerated dose (MTD)

Define the maximum tolerated dose (MTD) of image guided hypofractionated, focally dose escalated post-prostatectomy radiation.

Secondary Outcome Measures

The rate of PSA control

Kaplan-Meier survival analysis and effects of clinical variables on bPFS will be assessed by the Cox proportional hazards model.

Proportion of patients that have improvement in quality of life after treatment

The quality of life scores will be summarized at baseline and for each visit. Linear mixed effects model will be used to model quality of life scores at baseline and during and after treatment in which random intercept and random slope are used to account for patient-specific trajectory of quality of life scores.

List of adverse event frequency

Define the toxicity profile of image-guided, focally dose escalated prostate bed radiation in patients with a local or regional recurrence of prostate cancer after prostatectomy.

Full Information

NCT ID

NCT03388619

First Posted

December 30, 2017

Last Updated

September 30, 2023

Sponsor

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT03388619

Brief Title

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

Official Title

A Phase I Trial of Highly Conformal, Hypofractionated, Focally Dose Escalated Post-Prostatectomy Radiotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

September 25, 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 17, 2018 (Actual)

Primary Completion Date

July 1, 2027 (Anticipated)

Study Completion Date

December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

5. Study Description

Brief Summary

Background: Sometimes prostate cancer comes back after a person s prostate is removed. In this case, radiation is a common treatment. Radiation kills prostate cancer cells. It can be very effective. It is usually given in short doses almost every day for 6 or 7 weeks. Researchers want to see if a shorter schedule can be as effective. They want to see if that causes the same or fewer side effects. Usually, radiation is used to treat the entire area where the prostate was before surgery. In some patients, an area of tumor can be seen on scans. Researchers are also trying to see if they can give less dose to the area usually treated with radiation if the full dose is given to the tumor seen on scans. Objective: To find the shortest radiation schedule that people can tolerate without strong side effects. Eligibility: People at least 18 years old who have had a prostatectomy and will get radiation Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Scan that uses a small amount of radiation to make a picture of the body Scan that uses a magnetic field to make an image of the body Participants will provide documents that confirm their diagnosis. Participants may have a scan of the abdomen and pelvis. Before they start treatment, participants will have another physical exam and blood tests. Participants will get radiation each day Monday through Friday. Treatment may last 2, 3, or 4 weeks. Participants may provide a tissue sample from a previous procedure for research. Participants will answer questions about their general well-being and function. About 4-5 weeks after they finish radiation treatment, participants will have a follow-up visit. They will be examined and give a blood sample. They will have 6 follow-up visits for the next 2 years.

Detailed Description

BACKGROUND: Prostate cancer that recurs after prostatectomy (rising PSA) with no evidence of metastatic disease is often treated with radiation to the entire prostate bed to a dose of 66-72 Gy over 6-7 weeks. This treatment can provide PSA control in approximately 75% of patients, but may have associated genitourinary and gastrointestinal toxicity due to irradiation of the rectum, small bowel, and bladder. Imaging of prostate cancer has improved to the extent that recurrent disease is often identified in the prostate bed or in other pelvic sites. The current standard is to irradiate the entire prostate bed to the total dose. This trial will test the tolerability of accelerated treatment designed to yield a similar rate of late toxicity. In addition, in patients with visible tumor, it will test the feasibility of delivering a lower dose to the prostate bed and an integrated boost (simultaneous) to the visible tumor to allow a higher dose to visible tumor than can be delivered with standard approaches. OBJECTIVE: - Define the maximum tolerated dose (MTD) hypofractionation of image guided, focally dose escalated post-prostatectomy radiation. ELIGIBILITY: PSA recurrence after prostatectomy or indications for adjuvant radiation after prostatectomy. No evidence of distant metastases of prostate cancer (pelvic lymph nodes are allowed). Age greater than or equal to 18 years old ECOG performance status less than or equal to 1 DESIGN: This is a Phase I trial of hypofractionated, focal dose escalation with reduced dose prostate bed irradiation using image and pathologic guidance. The prostate bed will be treated with hypofractionated radiation and areas in the prostate bed or pelvis shown to have tumor on biopsy or with advanced imaging studies will be treated with an integrated boost to visible tumor. The treatment duration will be decreased sequentially in three Dose Level groups. Quality of life and functional outcomes such as urine, bowel, and erectile function will be assessed with questionnaires. A maximum of 48 patients will be enrolled.

6. Conditions and Keywords

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

Cancer Of Prostate, Prostate Neoplasms, Prostate Cancer, Neoplasms of Prostate, Prostatic Cancer

Keywords

Rising PSA, No evidence of metastatic disease, Entire Prostate Bed, Quality of Life, Irradiation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1/Prostate bed with integrated boost

Arm Type

Experimental

Arm Description

Dose to prostate bed with integrated boost

Arm Title

2/Prostate bed irradiation only

Arm Type

Experimental

Arm Description

Dose to prostate bed irradiation only

Intervention Type

Radiation

Intervention Name(s)

Dose to prostate bed with integrated boost

Intervention Description

Radiation will be delivered at an escalated dose to areas of recurrent prostate cancer identified on imaging and a reduced dose will be delivered to the entire prostate bed

Intervention Type

Radiation

Intervention Name(s)

Dose to prostate bed irradiation only

Intervention Description

Radiation will be delivered to the prostate bed only

Primary Outcome Measure Information:

Title

Define the maximum tolerated dose (MTD)

Description

Define the maximum tolerated dose (MTD) of image guided hypofractionated, focally dose escalated post-prostatectomy radiation.

Time Frame

3 weeks after radiation

Secondary Outcome Measure Information:

Title

The rate of PSA control

Description

Kaplan-Meier survival analysis and effects of clinical variables on bPFS will be assessed by the Cox proportional hazards model.

Time Frame

1 and 2 years after treatment

Title

Proportion of patients that have improvement in quality of life after treatment

Description

Time Frame

1 and 2 years after treatment

Title

List of adverse event frequency

Description

Define the toxicity profile of image-guided, focally dose escalated prostate bed radiation in patients with a local or regional recurrence of prostate cancer after prostatectomy.

Time Frame

3 weeks after radiation

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

INCLUSION CRITERIA: Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate. Indications for post-prostatectomy radiation exist: Disease progression (detectable PSA on two measurements obtained at least one month apart) or indications for adjuvant radiation exist (if undetectable PSA): pathologic T3, T4, N+ disease or positive margins (within 1 year of prostatectomy). Age greater than or equal to 18 years. ECOG performance status less than or equal to 1 (Karnofsky greater than or equal to 60) Ability of subject to understand and the willingness to sign a written informed consent document. Radiation is teratogenic; thus, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and up to 120 days after the last radiation. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately. HIV positive patients are included if CD4+ T-cell count > 200 cells/uL; on stable antiretroviral therapy for > 1 year with HIV viral load <200 copies/mL, and no history of opportunistic infections in > 1 year. EXCLUSION CRIETERIA: Patients who are receiving any other investigational agents concurrently. Documented metastases of prostate cancer outside of the pelvis (pelvic lymph nodes are allowed only if within the prostate bed region). History of radiation that would overlap with the intended treatment to the prostate bed. Known contraindications to radiation such as inflammatory bowel disease, active systemic lupus or scleroderma, or radiation hypersensitivity syndrome (Ataxia Telangiectasia or Fanconi s Anemia) Subjects with any coexisting medical or psychiatric condition which, in the opinion of the Investigator likely to interfere with study procedures and/or results. Medically indicated use of known radiosensitizing drugs (such as protease inhibitors)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Debbie Nathan, R.N.

Phone

(301) 451-8968

dnathan@mail.nih.gov

First Name & Middle Initial & Last Name or Official Title & Degree

Deborah E Citrin, M.D.

Phone

(240) 760-6206

citrind@mail.nih.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Deborah E Citrin, M.D.

Organizational Affiliation

National Cancer Institute (NCI)

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Institutes of Health Clinical Center

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20892

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

Phone

888-624-1937

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

.All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.

IPD Sharing Time Frame

Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.

IPD Sharing Access Criteria

Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. Genomic data are made available via dbGaP through requests to the data custodians.

Citations:

PubMed Identifier

28244407

Citation

Shaikh T, Li T, Handorf EA, Johnson ME, Wang LS, Hallman MA, Greenberg RE, Price RA Jr, Uzzo RG, Ma C, Chen D, Geynisman DM, Pollack A, Horwitz EM. Long-Term Patient-Reported Outcomes From a Phase 3 Randomized Prospective Trial of Conventional Versus Hypofractionated Radiation Therapy for Localized Prostate Cancer. Int J Radiat Oncol Biol Phys. 2017 Mar 15;97(4):722-731. doi: 10.1016/j.ijrobp.2016.12.034. Epub 2016 Dec 28.

Results Reference

background

PubMed Identifier

25728586

Citation

Christie DR, Sharpley CF, Bitsika V. Why do patients regret their prostate cancer treatment? A systematic review of regret after treatment for localized prostate cancer. Psychooncology. 2015 Sep;24(9):1002-11. doi: 10.1002/pon.3776. Epub 2015 Mar 1.

Results Reference

background

PubMed Identifier

27339115

Citation

Dearnaley D, Syndikus I, Mossop H, Khoo V, Birtle A, Bloomfield D, Graham J, Kirkbride P, Logue J, Malik Z, Money-Kyrle J, O'Sullivan JM, Panades M, Parker C, Patterson H, Scrase C, Staffurth J, Stockdale A, Tremlett J, Bidmead M, Mayles H, Naismith O, South C, Gao A, Cruickshank C, Hassan S, Pugh J, Griffin C, Hall E; CHHiP Investigators. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial. Lancet Oncol. 2016 Aug;17(8):1047-1060. doi: 10.1016/S1470-2045(16)30102-4. Epub 2016 Jun 20. Erratum In: Lancet Oncol. 2016 Aug;17 (8):e321.

Results Reference

background

Links:

URL

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2018-C-0028.html

Description

NIH Clinical Center Detailed Web Page

Learn more about this trial

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

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