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

• ClinicalTrials.gov Identifier: NCT03582774
• Recruitment Status: Recruiting
• First Posted: July 11, 2018
• Last Update Posted: January 14, 2020
• Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Jonsson Comprehensive Cancer Center

Study Description

Brief Summary:

To evaluate the success rate of salvage radiation therapy (SRT) for recurrence of prostate cancer after prostatectomy with and without planning based on 68Ga-PSMA-11 PET/CT.

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.

Routine care SRT involves either radiotherapy directed to the prostate bed alone, or the prostate bed and pelvic lymph nodes. In addition, the radiotherapy can be delivered either with or without concurrent ADT (typically for 6 months duration of ADT). The choice of treating the prostate bed alone vs prostate bed and pelvic lymph nodes, with or without ADT, is based upon clinico-pathologic features and practice patterns of the treating physician. The treating physician will be asked to describe their general treatment plan prior to randomization.

The treating physician will be encouraged to pursue their general treatment plan after randomization regardless of what arm the patient is randomized into. In some cases, due to specific anatomical features of the patient (for example, location of small bowel), or patient's preference (for example, patient may decline ADT), the general treatment plan may be modified during the radiotherapy planning process. However, the treating physician is encouraged not to use the results of the PSMA PET/CT, if patient receives this scan, to de-escalate therapy. For example, a negative PSMA PET/CT does not mean that the patient has no recurrent prostate cancer. Furthermore, a PSMA PET/CT showing PSMA positive disease in one or more pelvic nodes does not exclude the possibility of additional disease in the prostate bed, and vice versa.

Patients will be followed until either one of the following conditions occur: 5 years after the date of initiation of SRT, Biochemical progression, Diagnostic of metastatic disease, Initiation of any additional, salvage therapy, Death.

Study Design

• 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]
• Actual Study Start Date: July 12, 2018
• Estimated Primary Completion Date: September 2023
• Estimated Study Completion Date: July 2024

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Arm 1; Patient does not undergo 68Ga-PSMA-11 PET/CT for SRT planning.
Active Comparator: Arm 2; Patient undergoes 68Ga-PSMA-11 PET/CT for SRT planning.	Drug: 68Ga-PSMA-11; If 68Ga-PSMA-11 PET/CT scan detects PSMA-positive lesions in the pelvis: SRT will be performed per discretion of the treating radiation oncologist. SRT can be performed as routinely planned in accordance with the initial general treatment plan. SRT can also be performed with adapted/extended target volumes to include all pelvic PSMA-positive lesions within the radiation fields. SRT also may be performed with focal dose escalation on the PSMA-positive lesions if feasible. If 68Ga-PSMA-11 PET/CT scan detects PSMA-positive lesions outside the pelvis: treatment management will be performed as per discretion of the treating radiation oncologist. However, the patient will not be included in analysis of the primary endpoint. We assume that approximately 13% of subjects randomized to Arm 2 will be found to be ineligible for SRT and will not be included for further analysis.

Outcome Measures

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

Eligibility Criteria

• 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. -

Contacts and Locations

Contacts

Contact: Kiara Booker Adame; 310-206-7372; KMBooker@mednet.ucla.edu

Contact: Stephanie Lira; 310 206 7372; StephanieLira@mednet.ucla.edu

Locations

United States, California

UCLA; Recruiting

Los Angeles, California, United States, 90095

Contact: J Gartman

Sponsors and Collaborators

Jonsson Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Jeremie Calais, MD; University of California, Los Angeles

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Calais J, Czernin J, Fendler WP, Elashoff D, Nickols NG. Randomized prospective phase III trial of (68)Ga-PSMA-11 PET/CT molecular imaging for prostate cancer salvage radiotherapy planning [PSMA-SRT]. BMC Cancer. 2019 Jan 7;19(1):18. doi: 10.1186/s12885-018-5200-1. Erratum in: BMC Cancer. 2019 Jan 21;19(1):97.

• Responsible Party: Jonsson Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT03582774
• Other Study ID Numbers: 18-000484; NUC MED 18-000484 ( Other Identifier: JCCC Short Title )
• First Posted: July 11, 2018
• Last Update Posted: January 14, 2020
• Last Verified: November 2019

• 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