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Trial of 68Ga-PSMA-11 PET/CT Molecular Imaging for Prostate Cancer Salvage Radiotherapy Planning [PSMA-SRT]

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ClinicalTrials.gov Identifier: NCT03582774
Recruitment Status : Not yet recruiting
First Posted : July 11, 2018
Last Update Posted : July 13, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Brief Summary:
For men with a recurrence following radical prostatectomy, salvage external beam radiation therapy (SRT) can provide long-term disease control if the recurrence is encompassed within the treatment field and a sufficient radiation dose can be delivered to eradicate the residual/recurrent cancer. SRT offers long-term biochemical control in about 60% of patients. Target volume delineations for prostate cancer SRT after radical prostatectomy are usually drawn in the absence of visibly recurrent disease.

Condition or disease Intervention/treatment Phase
Recurrent Prostate Carcinoma Drug: 68Ga-PSMA-11 Phase 3

Detailed Description:

For men with a recurrence following radical prostatectomy, salvage external beam radiation therapy (SRT) can provide long-term disease control if the recurrence is encompassed within the treatment field and a sufficient radiation dose can be delivered to eradicate the residual/recurrent cancer. SRT offers long-term biochemical control in about 60% of patients. Target volume delineations for prostate cancer SRT after radical prostatectomy are usually drawn in the absence of visibly recurrent disease.

68Ga-PSMA-11 PET/CT detects recurrent prostate cancer with sensitivity superior to standard of care imaging at serum prostate specific antigen (PSA) values low enough to impact routine SRT planning (i.e. <1.0 ng/ml). 68Ga-PSMA-11 PET/CT imaging can improve patient selection for successful SRT by excluding patients with M1 disease where SRT would be futile (extra-pelvic disease is seen in at least 13% of patients with PSA <1.0 ng/ml) and by improving the coverage of the recurrent lesions by the pelvic radiation fields (out-of-field pelvic disease is seen in at least 7% of patients).

This phase III randomized trial aims at showing that 68Ga-PSMA-11 PET/CT improve the success rate of SRT after radical prostatectomy.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 193 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase III Randomized Trial of 68Ga-PSMA-11 PET/CT Molecular Imaging for Prostate Cancer Salvage Radiotherapy Planning [PSMA-SRT]
Estimated Study Start Date : July 30, 2018
Estimated Primary Completion Date : July 30, 2023
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Arm 1
Patient does not undergo 68Ga-PSMA-11 PET/CT for SRT planning. SRT will be performed as routinely planned. Other imaging is allowed if done per routine care.
Active Comparator: Arm 2
Patient undergoes 68Ga-PSMA-11 PET/CT for SRT planning.
Drug: 68Ga-PSMA-11
68Ga-PSMA-11 PET/CT detects recurrent prostate cancer with sensitivity superior to standard of care imaging at serum prostate specific antigen (PSA) values low enough to impact routine SRT planning (i.e. <1.0 ng/ml).




Primary Outcome Measures :
  1. Rate of biochemical progression-free survival [ Time Frame: Time Frame: From date of initiation of salvage radiation therapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years ]
    Success rate of SRT measured as biochemical progression-free survival after initiation of SRT. Biochemical progression is defined by PSA ≥ 0.2 ng/mL and rising after completion of SRT


Secondary Outcome Measures :
  1. 5-year progression-free survival rate [ Time Frame: 5 years ]
    5-year biochemical progression-free survival rate (from date of initiation of SRT)

  2. Metastasis free-survival [ Time Frame: 5 years ]
    Diagnostic of extra-pelvic metastatic (M1) disease can be obtained by any imaging or biopsy

  3. Rate of additional prostate cancer therapy initiation-free survival [ Time Frame: assessed up to 5 years ]
    From the initiation of salvage radiation therapy until the first documented initiation of any additional prostate cancer treatment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Prostate Cancer only occurs in male subjects
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histopathology proven prostate cancer
  2. Planned SRT for recurrence after primary prostatectomy
  3. PSA ≥ 0.1ng/ml at time of enrollment
  4. Willingness to undergo radiotherapy.
  5. Treating radiation oncologist intends to incorporate 68Ga-PSMA-11 PET/CT findings into the radiotherapy plan if patient undergoes 68Ga-PSMA-11 PET/CT -

Exclusion Criteria:

  1. Extra-pelvic metastasis on any imaging or biopsy
  2. Prior PSMA PET/CT
  3. Prior pelvic external beam radiation therapy (RT)
  4. Androgen deprivation therapy (ADT) within 3 months before 68Ga-PSMA-11 PET/CT
  5. Contraindications to radiotherapy (including active inflammatory bowel disease)
  6. Concurrent systemic therapy for prostate cancer with investigational agents. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03582774


Contacts
Contact: Soosan Roodbari 310-794-1596 SROODBARI@MEDNET.UCLA.EDU

Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jeremie Calais, MD University of California, Los Angeles

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03582774     History of Changes
Other Study ID Numbers: 18-000484
NUC MED 18-000484 ( Other Identifier: JCCC Short Title )
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases