Phase 1
N=30
Highly Conformal, Hypofractionated, Focally Dose Escalated Post-Prostatectomy Radiotherapy
Cancer Of Prostate · Prostate Neoplasms · Prostate Cancer · Neoplasms of Prostate · Prostatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03388619 ↗Enrolled (actual)
30
Serious AEs
3.3%
Results posted
May 2024
Primary outcome: Primary: Maximum Tolerated Dose (MTD) of Radiation Dose to Prostate Bed and Dose to Tumor Reported in Gray (Gy) — 36.4; 44.2; 47.1 Gray (Gy)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Prostate bed with integrated boost (Radiation); Prostate bed irradiation only (Radiation); Whole Body Bone Scan (Diagnostic_test); 18F-NaF PET Imaging (Diagnostic_test); CT (Diagnostic_test); mpMRI (Diagnostic_test); ADT (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) of Radiation Dose to Prostate Bed and Dose to Tumor Reported in Gray (Gy) |
36.4; 44.2; 47.1 | — |
| PRIMARY Maximum Tolerated Dose (MTD) of Radiation Dose to Prostate Bed and Dose to Tumor Reported in Fractions |
3.64; 4.42; 4.71 | — |
| SECONDARY Biochemical Progression Free Survival (bPFS) |
— | — |
| SECONDARY Changes in Quality of Life (QOL) Scores After Treatment |
— | — |
| SECONDARY Changes in Erectile Dysfunction After Treatment Measured by the Sexual Health Inventory for Men (SHIM) |
— | — |
| SECONDARY American Urologic Association Symptom Index Score (AUA-SI) |
— | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression Short Form (SF) 4a: |
— | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety Short Form (SF) 4a: |
— | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) - Psychosocial Impact Positive Short Form (SF) 4a |
— | — |
| SECONDARY Decision Regret Scale (DRS) |
— | — |
| SECONDARY Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research |
0; 0; 0; 0; 0; 0 | — |
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.
Eligibility Criteria
- INCLUSION CRITERIA:
- Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate.
- Indications for post-prostatectomy radiation exist:
- Disease progression (detectable prostate-specific antigen (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.
- Eastern Cooperative Oncology Group (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.
- Human immunodeficiency virus (HIV) positive patients are included if CD4+ (cytotoxic T cells) T-cell count > 200 cells/uL; on stable antiretroviral therapy for > 1 year with HIV viral load 1 year.
EXCLUSION CRITERIA
- 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)
Data sourced from ClinicalTrials.gov (NCT03388619). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.